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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050010 / PAS001 |
| Date Original Protocol Accepted |
08/14/2006
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| Date Current Protocol Accepted |
08/14/2006
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| Study Name |
PRODISC-L Long Term Study
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| Device Name |
PRODISC -L TOTAL DISC REPLACEMENT DEVICE
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is continuation of the IDE study, which was a multi-center, prospective, randomized, controlled clinical trial. The objective of PAS is to evaluate the long-term safety and effectiveness of Prodisc -L Total Disc Replacement to spinal fusion surgery in the treatment of discogenic pain associated with Degenerative Disc Disease in the lumbosacral spine.
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| Study Population |
Study population is as per device indication. The study population consists of all patients from IDE study who were enrolled and treated without major protocol violation. This device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one levelfrom L3-Sl. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade I spondylolisthesis at the involved level. Patients receiving the PRODISC -L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the PRODISC Total Disc Replacement.
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| Sample Size |
A total of 286 patients (161 randomized investigational subjects, 75 randomized control subjects, and 50 non-randomized investigational subjects) enrolled in the PAS
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| Key Study Endpoints |
The outcome measures in the PAS include patient self-assessment on Oswestry score, SF-36, Pain and satisfaction; physical & neurological examination and radiographic evaluation of the implanted level and adjacent segments. The composite overall success is defined as: - Oswestry score improves by at least 15% over baseline value;- SF-36 score will be improved; - Maintained or improved neurological parameters, i.e., motor, sensory, reflexes and straight leg raise tests; - No re-operations were required to modify or remove the implant (Prodisc -L group); no re-operations were required to modify the fusion site or correct a complication with an implant (Fusion group). - Radiological success as assessed by independent radiographic review.
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| Follow-up Visits and Length of Follow-up |
The subjects were followed at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-operation in the PMA study. They will be followed annually after 24 month, up to 60 month post-operation in PAS.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
161 randomized investigational subjects, 50 training investigational subjects, and 75 control subjects. Overall 286 patients continued participation from the IDE study.
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| Actual Number of Sites Enrolled |
17 sites were enrolled for the Post-Approval Study.
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| Patient Follow-up Rate |
60.2%, 60.1% and 82.5% were the overall follow up rates at 36, 48, and 60 months, respectively.
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| Final Safety Findings |
During the 3 years of the PAS, there were several AEs with higher occurrence in the ProDisc randomized group compared to the fusion randomized group: infection/other non wound (4 vs. 1); back pain (18 vs. 4), pain ¿ back and lower extremities (10 vs. 5), surgery other (16 vs. 7).
All AEs involving pain considered together look definitely higher in the ProDisc randomized group.
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| Final Effect Findings |
At month 60 non-inferiority was demonstrated for Overall Success (p=0.0099) and Overall Success (Secondary Analyses) (p=0.0101).
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| Study Strengths & Weaknesses |
The main strength of the study is the randomized design. The main weakness of the study is the relatively low follow up rate, especially during follow up visits before the final visit; this may partially hamper the validity of the randomized comparison, since loss to follow up may not be independent of randomization group as well as patients outcomes.
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| Recommendations for Labeling Changes |
Yes.
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