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The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.
This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Experimental | A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
If not using Harvest Graft Delivery Kit:
|
|
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Active Comparator | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows:
|
|
| Autograft | Active Comparator | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Device | Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | Fusion status assessed via CT scan by an independent radiologist. | Month 12 Post-Operation |
| Oswestry Disability Index (ODI) Score at Pre-Op Visit | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Pre-Operation Visit (Day 0) |
| ODI Score at Week 6 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Week 6 Post-Operation |
| ODI Score at Month 3 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Passias | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Marrow Aspirate Concentrate (BMAC) + Allograft | A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
If not using Harvest Graft Delivery Kit:
Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. |
| FG001 | Recombinant Human Bone Morphogenetic Protein-2 (BMP) | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows:
Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. |
| FG002 | Autograft | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Marrow Aspirate Concentrate (BMAC) + Allograft | A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
If not using Harvest Graft Delivery Kit:
Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | Fusion status assessed via CT scan by an independent radiologist. | Posted | Count of Participants | Participants | Month 12 Post-Operation |
|
Month 24 Post-Operation (2 years)
Adverse events related to study will be detected from follow up visits by the patient and during the post-operative period by the principal investigator and co-investigators, through physical exam assessment and reviewing x-rays and CT scans of the subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bone Marrow Aspirate Concentrate (BMAC) + Allograft | A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
If not using Harvest Graft Delivery Kit:
Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Themistocles Protopsaltis | NYU Langone Health | 646-501-7200 | themistocles.protopsaltis@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2024 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Device | INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. |
|
|
| Autograft | Procedure | Autograft with bone marrow aspirate. |
|
| Month 3 Post-Operation |
| ODI Score at Month 6 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Month 6 Post-Operation |
| ODI Score at Month 12 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Month 12 Post-Operation |
| ODI Score at Month 24 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Month 24 Post-Operation |
| Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Pre-Operation Visit (Day 0) |
| NRS - Back Pain Score at Week 6 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Week 6 Post-Operation |
| NRS - Back Pain Score at Month 3 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Month 3 Post-Operation |
| NRS - Back Pain Score at Month 6 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Month 6 Post-Operation |
| NRS - Back Pain Score at Month 12 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Month 12 Post-Operation |
| NRS - Back Pain Score at Month 24 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Month 24 Post-Operation |
| Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Pre-Operation Visit (Day 0) |
| SF-12 - PCS Score at Week 6 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Week 6 Post-Operation |
| SF-12 - PCS Score at Month 3 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Month 3 Post-Operation |
| SF-12 - PCS Score at Month 6 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Month 6 Post-Operation |
| SF-12 - PCS Score at Month 12 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Month 12 Post-Operation |
| SF-12 - PCS Score at Month 24 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Month 24 Post-Operation |
| SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Pre-Operation Visit (Day 0) |
| SF-12 - MCS Score at Week 6 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Week 6 Post-Operation |
| SF-12 - MCS Score at Month 3 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Month 3 Follow-Up Post-Operation |
| SF-12 - MCS Score at Month 6 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Month 6 Post-Operation |
| Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Pre-Operation Visit (Day 0) |
| EQ-5D Score at Week 6 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Week 6 Post-Operation |
| EQ-5D Score at Month 3 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Month 3 Post-Operation |
| EQ-5D Score at Month 6 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Month 6 Post-Operation |
| EQ-5D Score at Month 12 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Month 12 Post-Operation |
| EQ-5D Score at Month 24 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Month 24 Post-Operation |
| Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Pre-Operation Visit (Day 0) |
| PCS Score at Week 6 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Week 6 Post-Operation |
| PCS Score at Month 3 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Month 3 Post-Operation |
| PCS Score at Month 6 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Month 6 Post-Operation |
| PCS Score at Month 12 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Month 12 Post-Operation |
| PCS Score at Month 24 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Month 24 Post-Operation |
| Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Pre-Operation Visit (Day 0) |
| PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Week 6 Post-Operation |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Month 3 Post-Operation |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Month 6 Post-Operation |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Month 12 Post-Operation |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Month 24 Post-Operation |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Pre-Operation Visit (Day 0) |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Week 6 Post-Operation |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Month 3 Post-Operation |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Month 6 Post-Operation |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Month 12 Post-Operation |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Month 24 Post-Operation |
| PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Pre-Operation Visit (Day 0) |
| PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Week 6 Post-Operation |
| PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Month 3 Post-Operation |
| PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Month 6 Post-Operation |
| PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Month 12 Post-Operation |
| PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Month 24 Post-Operation |
| PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Pre-Operation Visit (Day 0) |
| PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Week 6 Post-Operation |
| PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Month 3 Post-Operation |
| PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Month 6 Post-Operation |
| PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Month 12 Post-Operation |
| PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Month 24 Post-Operation |
| Length of Operation | Intraoperative Period (Day 0) (typically between 2-7 hours) |
| Length of Hospital Stay | From admission up to discharge (Up to Year 2 Post-Operation) |
| Blood Loss During Procedure | Intraoperative Period (Day 0) (typically between 2-7 hours) |
| Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | Number of participants taking OTC drugs for pain relief. | Pre-Operation Visit (Day 0) |
| Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | Number of participants taking OTC drugs for pain relief. | Week 6 Post-Operation |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | Number of participants taking OTC drugs for pain relief. | Month 3 Post-Operation |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | Number of participants taking OTC drugs for pain relief. | Month 6 Post-Operation |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | Number of participants taking OTC drugs for pain relief. | Month 12 Post-Operation |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | Number of participants taking OTC drugs for pain relief. | Month 24 Post-Operation |
| Number of Participants With Surgical Complications During Operation | Intraoperative Period (Day 0) (typically between 2-7 hours) |
| Number of Participants With Surgical Complications at Week 6 Follow-Up | Week 6 Post-Operation |
| Number of Participants With Surgical Complications at Month 3 Follow-Up | Month 3 Post-Operation |
| Number of Participants With Surgical Complications at Month 6 Follow-Up | Month 6 Post-Operation |
| Number of Participants With Surgical Complications at Month 12 Follow-Up | Month 12 Post-Operation |
| Number of Participants With Surgical Complications at Month 24 Follow-Up | Month 24 Post-Operation |
| SF-12 - MCS Score at Month 12 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Month 12 Post-Operation |
| SF-12 - MCS Score at Month 24 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Month 12 Post-Operation |
| BG001 | Recombinant Human Bone Morphogenetic Protein-2 (BMP) | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows:
Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. |
| BG002 | Autograft | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate. |
| BG003 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Recombinant Human Bone Morphogenetic Protein-2 (BMP) | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows:
Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. |
| OG002 | Autograft | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate. |
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| Primary | Oswestry Disability Index (ODI) Score at Pre-Op Visit | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Pre-Operation Visit (Day 0) |
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| Primary | ODI Score at Week 6 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Week 6 Post-Operation |
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| Primary | ODI Score at Month 3 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Month 3 Post-Operation |
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| Primary | ODI Score at Month 6 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Month 6 Post-Operation |
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| Primary | ODI Score at Month 12 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Month 12 Post-Operation |
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| Primary | ODI Score at Month 24 Follow-Up | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. | Posted | Mean | Standard Deviation | Percentage score | Month 24 Post-Operation |
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| Primary | Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation Visit (Day 0) |
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| Primary | NRS - Back Pain Score at Week 6 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Week 6 Post-Operation |
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| Primary | NRS - Back Pain Score at Month 3 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Month 3 Post-Operation |
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| Primary | NRS - Back Pain Score at Month 6 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Month 6 Post-Operation |
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| Primary | NRS - Back Pain Score at Month 12 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| Primary | NRS - Back Pain Score at Month 24 Follow-Up | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. | Posted | Mean | Standard Deviation | score on a scale | Month 24 Post-Operation |
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| Primary | Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation Visit (Day 0) |
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| Primary | SF-12 - PCS Score at Week 6 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Week 6 Post-Operation |
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| Primary | SF-12 - PCS Score at Month 3 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 3 Post-Operation |
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| Primary | SF-12 - PCS Score at Month 6 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 6 Post-Operation |
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| Primary | SF-12 - PCS Score at Month 12 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| Primary | SF-12 - PCS Score at Month 24 Follow-Up | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 24 Post-Operation |
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| Primary | SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation Visit (Day 0) |
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| Primary | SF-12 - MCS Score at Week 6 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Week 6 Post-Operation |
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| Primary | SF-12 - MCS Score at Month 3 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 3 Follow-Up Post-Operation |
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| Primary | SF-12 - MCS Score at Month 6 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 6 Post-Operation |
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| Primary | Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation Visit (Day 0) |
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| Primary | EQ-5D Score at Week 6 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Week 6 Post-Operation |
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| Primary | EQ-5D Score at Month 3 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Month 3 Post-Operation |
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| Primary | EQ-5D Score at Month 6 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Month 6 Post-Operation |
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| Primary | EQ-5D Score at Month 12 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| Primary | EQ-5D Score at Month 24 Follow-Up | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. | Posted | Mean | Standard Deviation | score on a scale | Month 24 Post-Operation |
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| Primary | Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation Visit (Day 0) |
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| Primary | PCS Score at Week 6 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Week 6 Post-Operation |
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| Primary | PCS Score at Month 3 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Month 3 Post-Operation |
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| Primary | PCS Score at Month 6 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Month 6 Post-Operation |
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| Primary | PCS Score at Month 12 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| Primary | PCS Score at Month 24 Follow-Up | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. | Posted | Mean | Standard Deviation | score on a scale | Month 24 Post-Operation |
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| Primary | Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Pre-Operation Visit (Day 0) |
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| Primary | PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Week 6 Post-Operation |
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| Primary | PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Month 3 Post-Operation |
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| Primary | PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Month 6 Post-Operation |
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| Primary | PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Month 12 Post-Operation |
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| Primary | PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. | Posted | Mean | Standard Deviation | T-score | Month 24 Post-Operation |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Pre-Operation Visit (Day 0) |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Week 6 Post-Operation |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Month 3 Post-Operation |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Month 6 Post-Operation |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Month 12 Post-Operation |
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| Primary | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. | Posted | Mean | Standard Deviation | T-score | Month 24 Post-Operation |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Pre-Operation Visit (Day 0) |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Week 6 Post-Operation |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Month 3 Post-Operation |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Month 6 Post-Operation |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Month 12 Post-Operation |
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| Primary | PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. | Posted | Mean | Standard Deviation | T-score | Month 24 Post-Operation |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Pre-Operation Visit (Day 0) |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Week 6 Post-Operation |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Month 3 Post-Operation |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Month 6 Post-Operation |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Month 12 Post-Operation |
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| Primary | PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. | Posted | Mean | Standard Deviation | T-score | Month 24 Post-Operation |
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| Primary | Length of Operation | Posted | Mean | Standard Deviation | minutes | Intraoperative Period (Day 0) (typically between 2-7 hours) |
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| Primary | Length of Hospital Stay | Posted | Mean | Standard Deviation | Days | From admission up to discharge (Up to Year 2 Post-Operation) |
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| Primary | Blood Loss During Procedure | Posted | Mean | Standard Deviation | Millilitres | Intraoperative Period (Day 0) (typically between 2-7 hours) |
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| Primary | Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Pre-Operation Visit (Day 0) |
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| Primary | Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Week 6 Post-Operation |
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| Primary | Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Month 3 Post-Operation |
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| Primary | Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Month 6 Post-Operation |
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| Primary | Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Month 12 Post-Operation |
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| Primary | Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | Number of participants taking OTC drugs for pain relief. | Posted | Count of Participants | Participants | Month 24 Post-Operation |
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| Primary | Number of Participants With Surgical Complications During Operation | Posted | Count of Participants | Participants | Intraoperative Period (Day 0) (typically between 2-7 hours) |
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| Primary | Number of Participants With Surgical Complications at Week 6 Follow-Up | Posted | Count of Participants | Participants | Week 6 Post-Operation |
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| Primary | Number of Participants With Surgical Complications at Month 3 Follow-Up | Posted | Count of Participants | Participants | Month 3 Post-Operation |
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| Primary | Number of Participants With Surgical Complications at Month 6 Follow-Up | Posted | Count of Participants | Participants | Month 6 Post-Operation |
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| Primary | Number of Participants With Surgical Complications at Month 12 Follow-Up | Posted | Count of Participants | Participants | Month 12 Post-Operation |
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| Primary | Number of Participants With Surgical Complications at Month 24 Follow-Up | Posted | Count of Participants | Participants | Month 24 Post-Operation |
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| Primary | SF-12 - MCS Score at Month 12 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| Primary | SF-12 - MCS Score at Month 24 Follow-Up | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. | Posted | Mean | Standard Deviation | score on a scale | Month 12 Post-Operation |
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| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Recombinant Human Bone Morphogenetic Protein-2 (BMP) | 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows:
Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. | 0 | 20 | 0 | 20 | 6 | 20 |
| EG002 | Autograft | As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion. Autograft: Autograft with bone marrow aspirate. | 0 | 19 | 0 | 19 | 4 | 19 |
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Non-union | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
Not provided