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The study was terminated early due to slow enrollment and difficulties with long-term follow-up
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The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | All adverse events will be documented including device related, procedure related and additional serious adverse events. | 24 months |
| Fusion Status on CT at 12 Months | Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Assessments | X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Subjects will be identified from the surgeon's practice.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15014276 | Background | Cammisa FP Jr, Lowery G, Garfin SR, Geisler FH, Klara PM, McGuire RA, Sassard WR, Stubbs H, Block JE. Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: a prospective controlled trial employing a side-by-side comparison in the same patient. Spine (Phila Pa 1976). 2004 Mar 15;29(6):660-6. doi: 10.1097/01.brs.0000116588.17129.b9. | |
| 16227892 |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | EVEREST/VESUVIUS Demineralized Fibers | This group involves patients treated with the VESUVIUS Demineralized Fibers and EVEREST system that had:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Demographics and Baseline Characteristics | Demographics and Baseline Characteristics (Patient Population) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Adverse Events | All adverse events will be documented including device related, procedure related and additional serious adverse events. | Posted | Number | participants | 24 months |
|
From Operative to 24+ Months
Any untoward medical occurrence in a subject undergoing surgery in this trial which does not necessarily have a causal relationship with this intervention. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the one of the devices. Any AE that occurs during the subject's participation in the study will be recorded on the Adverse Event case report form.
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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 | Participants With Adverse Events | Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events. 3 of the 25 SAE participants did not experience a non-SAE events. The other 22 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marissa Conrad, Senior Director of Clinical and Medical Affairs | Stryker Spine | 201-749-8162 | marissa.conrad@stryker.com |
Not provided
| 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 | Mar 3, 2015 | Jan 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12m |
| Radiographic Assessments | X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration | 12 Months and 24 Months |
| Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%. | Baseline (Pre-Op), 24 months |
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain | Baseline (up to 8 weeks post-operatively) to 24 months |
| Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life. | Baseline (up to 8 weeks post-operatively) to 24 months |
| Patient Satisfaction | Patient Satisfaction at 12 Mo and 24 Mo | 12 months, 24 months |
| Length of Surgery Time | The length of the surgical procedure from the initial incision to final closure. | At time of surgery |
| Length of Anesthesia Time | The length of time the patient is under anesthesia. | At time of surgery |
| Estimated Blood Loss | The amount of blood loss over the entire length of the surgery | At time of surgery |
| Length of Hospital Stay | The length of the hospital stay from the date of admission to the date of discharge . | Admission to discharge |
| Time to Return to Work/School | The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions. | Pre-Op to 24 months |
| Use of Narcotics Post-surgery | The types and dosages of any narcotics taken by the patient post-surgery will be documented. | Pre-Op to 24 months |
| Background |
| Chen WJ, Tsai TT, Chen LH, Niu CC, Lai PL, Fu TS, McCarthy K. The fusion rate of calcium sulfate with local autograft bone compared with autologous iliac bone graft for instrumented short-segment spinal fusion. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2293-7. doi: 10.1097/01.brs.0000182087.35335.05. |
| 16094268 | Background | Glassman SD, Dimar JR, Carreon LY, Campbell MJ, Puno RM, Johnson JR. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1694-8. doi: 10.1097/01.brs.0000172157.39513.80. |
| 16371892 | Background | Vaccaro AR, Anderson DG, Patel T, Fischgrund J, Truumees E, Herkowitz HN, Phillips F, Hilibrand A, Albert TJ, Wetzel T, McCulloch JA. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine (Phila Pa 1976). 2005 Dec 15;30(24):2709-16. doi: 10.1097/01.brs.0000190812.08447.ba. |
| 17047540 | Background | Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft. Spine (Phila Pa 1976). 2006 Oct 15;31(22):2534-9; discussion 2540. doi: 10.1097/01.brs.0000240715.78657.81. |
| 19940728 | Background | Niu CC, Tsai TT, Fu TS, Lai PL, Chen LH, Chen WJ. A comparison of posterolateral lumbar fusion comparing autograft, autogenous laminectomy bone with bone marrow aspirate, and calcium sulphate with bone marrow aspirate: a prospective randomized study. Spine (Phila Pa 1976). 2009 Dec 1;34(25):2715-9. doi: 10.1097/BRS.0b013e3181b47232. |
| 20139805 | Background | Taghavi CE, Lee KB, Keorochana G, Tzeng ST, Yoo JH, Wang JC. Bone morphogenetic protein-2 and bone marrow aspirate with allograft as alternatives to autograft in instrumented revision posterolateral lumbar spinal fusion: a minimum two-year follow-up study. Spine (Phila Pa 1976). 2010 May 15;35(11):1144-50. doi: 10.1097/BRS.0b013e3181bb5203. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | The study Case Report Forms did not include Race/Ethnicity | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | lbs/(in^2)*703 |
|
| Tobacco Use | Count of Participants | Participants |
|
AEs and SAEs that occurred at the beginning of the study from 3 to 6 Months
| OG003 | 6 to 12 Months | AEs and SAEs that occurred at the beginning of the study from 6 to 12 Months |
| OG004 | 12 to 24+ Months | AEs and SAEs that occurred at the beginning of the study from 12 to 24+ Months |
| OG005 | Overall | Overall AEs and SAEs |
|
|
| Primary | Fusion Status on CT at 12 Months | Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes. | Image Assessed at Visit | Posted | Count of Units | Number of Image Assessed | 12 months | Number of Image Assessed | Number of Image Assessed |
|
|
|
| Secondary | Radiographic Assessments | X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include:
| Each Arm/group has different overall number of participants assessed. | Posted | Count of Participants | Participants | 12m |
|
|
|
| Secondary | Radiographic Assessments | X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration | The participants data analyzed differ from the overall number of participants for the Arms. Cages were optional per protocol as such the decrease in the number of participants. | Posted | Count of Participants | Participants | 12 Months and 24 Months |
|
|
|
| Secondary | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%. | While 53 participants completed the study, 1 patient did not complete the survey at 24 Month. 2 patient did not complete the survey at 12 Month. 5 patient did not complete the survey at 6 Month. 4 patient did not complete the survey at 3 Month. 2 patient did not complete the survey at Initial Post-Op. 1 patient did not complete the survey at Pre-Op. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-Op), 24 months |
|
|
|
| Secondary | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain | While 53 participants completed the study, 1-2 patients did not complete the survey | Posted | Mean | Standard Deviation | score on a scale | Baseline (up to 8 weeks post-operatively) to 24 months |
|
|
|
| Secondary | Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life. | While 53 participants completed the study, 1 patient did not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline (up to 8 weeks post-operatively) to 24 months |
|
|
|
| Secondary | Patient Satisfaction | Patient Satisfaction at 12 Mo and 24 Mo | All participants for both intervals filled out the surveys | Posted | Count of Participants | Participants | 12 months, 24 months |
|
|
|
| Secondary | Length of Surgery Time | The length of the surgical procedure from the initial incision to final closure. | 5 Subjects did not have a surgical time recorded | Posted | Mean | Standard Deviation | Hours | At time of surgery |
|
|
|
| Secondary | Length of Anesthesia Time | The length of time the patient is under anesthesia. | 6 Subjects did not have anesthesia time recorded | Posted | Mean | Standard Deviation | Hours | At time of surgery |
|
|
|
| Secondary | Estimated Blood Loss | The amount of blood loss over the entire length of the surgery | 1 Subject did not have the amount of blood loss recorded | Posted | Mean | Standard Deviation | Cubic Centimeters | At time of surgery |
|
|
|
| Secondary | Length of Hospital Stay | The length of the hospital stay from the date of admission to the date of discharge . | All patients are accounted for | Posted | Mean | Standard Deviation | Days | Admission to discharge |
|
|
|
| Secondary | Time to Return to Work/School | The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions. | Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row. | Posted | Count of Participants | Participants | Pre-Op to 24 months |
|
|
|
| Secondary | Use of Narcotics Post-surgery | The types and dosages of any narcotics taken by the patient post-surgery will be documented. | Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row. | Posted | Count of Participants | Participants | Pre-Op to 24 months |
|
|
|
| 0 |
| 108 |
| 25 |
| 108 |
| 73 |
| 108 |
| Gastrointestinal anastomotic stenosis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cervical radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Post procedural | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint hyperextension | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dural tear | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Device failure | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Iliac vein perforation | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myocardial infarction | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye contusion | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incision site impaired healing | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Post procedural fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Adjacent segment degeneration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Implant site erosion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal procedural complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Rotator cuff syndrome | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Culture negative | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Electrocardiogram | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Electrocardiogram ambulatory | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Lasegue's test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic neuropathy | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incomplete spinal fusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Limb asymmetry | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lower limb fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle strain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Restless legs syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sacroilitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Wrist fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dural tear | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lumbar spinal stenosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incision site impaired healing | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Confusion postoperative | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bladder dysfunction | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Calculus urinal | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nephrolithiasis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Testicular swelling | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin laceration | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Incisional drainage | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Perthes disease | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The Institution/PI shall not disclose/use any confidential/proprietary information (CI) disclosed to/developed by the Institution during the study. Institution/PI agree to hold the results of the Study in confidence, and shall not disclose them except with prior written consent of K2M. Institution agrees to submit any Articles to K2M for review prior to publication and agrees to edit out any confidential information identified by K2M.
| D055009 |
| Spondylosis |
| Partial Consolidation |
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| Absent |
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| Unknown |
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| 1:1 (Vesuvius Fibers: BMA) |
|
|
| Other |
|
|
| 1 Level |
|
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| 2 Levels |
|
|
| L3-L4 |
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| L4-L5 |
|
|
| L5-S1 |
|
|
| Loosening |
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| Fracture |
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| Absent |
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| Partial Consolidation |
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| Bridging/Fusion |
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| Unable to assess |
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| 24 Mo Hardware Condition |
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| 12 Mo Cage Condition |
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| 24 Mo Cage Condition |
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|
| Change from Baseline |
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| Not Reported |
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| Repeat Procedure |
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| Not attending work/school by choice |
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| Unable to go due to back/leg pain/conditions |
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| Attending work/school with some restrictions |
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| Attending work/school with no restrictions |
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| Missing |
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| Non-narcotics or NSAIDs |
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| Intermittent short-acting narcotics |
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| Chronic daily short-acting narcotics |
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| Chronic daily long-acting narcotics |
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| IV or injected narcotics |
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| Epidural/Facet injections |
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| Missing |
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| Non-Back Meds |
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