Spinal Diseases
Conditions
Brief summary
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.
Interventions
DEVICEProDisc
Total disc replacement with ProDisc
PROCEDURESpinal Fusion
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires: a)Back and/or leg (radicular) pain; and b)Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height \>2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon. * Age between 18 and 60 years. * Failed at least 6 months of conservative treatment. * Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%)(Interpreted as moderate/severe disability). * Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms. * Signed informed consent.
Exclusion criteria
* No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated. * Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions. * Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum. * Prior fusion surgery at any vertebral level. * Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma. * Radiographic confirmation of facet joint disease or degeneration. * Lytic spondylolisthesis or spinal stenosis. * Degenerative spondylolisthesis of grade \>1. * Back or leg pain of unknown etiology. * Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than * 1.0. The World Health Organization defines osteoporosis as a DEXA T score less than or equal to -2.5. * Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above). * Morbid obesity defined as a body mass index \>40 or a weight more than 100 lbs. over ideal body weight. * Pregnant or interested in becoming pregnant in the next 3 years. * Active infection - systemic or local. * Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). * Rheumatoid arthritis or other autoimmune disease. * Systemic disease including AIDS, HIV, Hepatitis. * Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success | 24 Months | Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: 1. Same as above 2. Same as above 3. Same as above 4. No re-operations to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-Level Fusion Circumferential fusion at a single lumbar level. | 80 |
| 1-Level ProDisc Total disc arthroplasty with the ProDisc device at one spinal lumbar level. | 162 |
| 1-Level ProDisc (Non-randomized) Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level. | 50 |
| 2-Level Fusion Circumferential fusion at two adjacent lumbar levels. | 72 |
| 2-Level ProDisc Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels. | 165 |
| 2-Level ProDisc (Continued Access) Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months. | 259 |
| Total | 788 |
Baseline characteristics
| Characteristic | 1-Level Fusion | 1-Level ProDisc | 1-Level ProDisc (Non-randomized) | 2-Level Fusion | 2-Level ProDisc | 2-Level ProDisc (Continued Access) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 7.6 | 39.6 years STANDARD_DEVIATION 8 | 37.9 years STANDARD_DEVIATION 8 | 41.8 years STANDARD_DEVIATION 7.8 | 41.8 years STANDARD_DEVIATION 7.7 | 40.5 years STANDARD_DEVIATION 7.4 | 40.3 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 80 participants | 162 participants | 50 participants | 72 participants | 165 participants | 259 participants | 788 participants |
| Sex: Female, Male Female | 43 Participants | 79 Participants | 30 Participants | 33 Participants | 70 Participants | 103 Participants | 358 Participants |
| Sex: Female, Male Male | 37 Participants | 83 Participants | 20 Participants | 39 Participants | 95 Participants | 156 Participants | 430 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 73 / 80 | 153 / 162 | 46 / 50 | 69 / 72 | 153 / 165 | 219 / 259 |
| serious Total, serious adverse events | 27 / 80 | 43 / 162 | 16 / 50 | 23 / 72 | 39 / 165 | 38 / 259 |
Outcome results
Primary
Overall Success
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: 1. Same as above 2. Same as above 3. Same as above 4. No re-operations to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Time frame: 24 Months
Population: Patients who completed all 24 month visit analyses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1-Level Fusion | Overall Success | 45.1 percentage of overall successes |
| 1-Level ProDisc | Overall Success | 63.5 percentage of overall successes |
| 1-Level ProDisc (Non-randomized) | Overall Success | 66.7 percentage of overall successes |
| 2-Level Fusion | Overall Success | 53.3 percentage of overall successes |
| 2-Level ProDisc | Overall Success | 59.4 percentage of overall successes |
| 2-Level ProDisc (Continued Access) | Overall Success | 58.6 percentage of overall successes |
Primary
Overall Success
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations required to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Time frame: 60 Months
Population: Patients who completed all 60 month visit analyses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1-Level Fusion | Overall Success | 50.0 percentage of overall successes |
| 1-Level ProDisc | Overall Success | 53.7 percentage of overall successes |
| 1-Level ProDisc (Non-randomized) | Overall Success | 56.4 percentage of overall successes |
| 2-Level Fusion | Overall Success | 50.9 percentage of overall successes |
| 2-Level ProDisc | Overall Success | 55.2 percentage of overall successes |