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Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.
The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Interbody fusions with Anterior Plating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interbody Fusion | Device | allograft spacer + anterior plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Successful Radiographic Fusion | CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline. | Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability. | 24 Months |
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Inclusion Criteria:
One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:
Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:
Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
Skeletally mature and at least 18 years of age
Signs the approved Informed Consent Document
Is available for long term follow-up and interval visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirkham Wood, MD | Massachusetts General Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Interbody fusions with Anterior Plating |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
178 subjects were enrolled in the study but 16 of these were never treated. A total of 162 subjects were both enrolled and treated.
Of the 162 enrolled and treated subjects, 12 were excluded for protocol deviations. Therefore, the overall number of baseline participants was 150 subjects per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Interbody fusions with Anterior Plating |
| 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 Subjects With Successful Radiographic Fusion | CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success. | Posted | Count of Participants | Participants | 24 Months |
|
|
24 months
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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 | Treatment | Interbody fusions with Anterior Plating |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken Components | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New Onset of Pain | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Synthes Spine | 610-719-5942 | knappk@synthes.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Pain Scores on the Numeric Rating Scale (NRS) | The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain) | Baseline and 24 Months |
| Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline | The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible | 24 Months |
| Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline | The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Baseline and 24 Months |
| SF-12 Physical Composite Score (PCS) Summary | The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Baseline and 24 Months |
| SF-12 Mental Composite Score (MCS) Summary | The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Baseline and 24 Months |
| Oswestry Disability Index (ODI) Summary | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible | Baseline and 24 Months |
| Protocol Violation |
|
| Randomized but Never Treated |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline. | Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | Pain Scores on the Numeric Rating Scale (NRS) | The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 Months |
|
|
|
| Secondary | Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline | The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| Secondary | Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline | The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Posted | Count of Participants | Participants | Baseline and 24 Months |
|
|
|
| Secondary | SF-12 Physical Composite Score (PCS) Summary | The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 24 Months |
|
|
|
| Secondary | SF-12 Mental Composite Score (MCS) Summary | The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 24 Months |
|
|
|
| Secondary | Oswestry Disability Index (ODI) Summary | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 24 Months |
|
|
|
| 19 |
| 150 |
| 77 |
| 150 |
| Device Slippage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| New Onset of Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pseudoarthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Soft Tissue Damage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | Non-systematic Assessment |
|
| Vascular Injury | Vascular disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Disc Fragment Dislodged | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pseudoarthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vascular Injury | Vascular disorders | Non-systematic Assessment |
|
| Numbness/Tingling Sensation | Nervous system disorders | Non-systematic Assessment |
|
| Broken Components | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Neural Structure Injury | Nervous system disorders | Non-systematic Assessment |
|
| Thrombosis/Thrombophlegitis | Vascular disorders | Non-systematic Assessment |
|
| Adjacent Segment Degeneration | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cysts Found in and around Spacer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Device Slippage | Product Issues | Non-systematic Assessment |
|
| Disc Fragment Dislodged | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Edema | General disorders | Non-systematic Assessment |
|
| Fracture of Vertebrae | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hematoma/Seroma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Intestinal Blockage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irregular Menstrual Cycle | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Motor Vehicle Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Retrograde Ejaculation | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Soft Tissue Damage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
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