Five-Year Results of the ProDisc-L Multicenter, Prospective, Randomized, Controlled Trial Comparing ProDisc-L With Circumferential Spinal Fusion for Single-Level Disabling Degenerative Disk Disease

doi:10.1053/j.semss.2011.11.006

Seminars in Spine Surgery

Volume 24, Issue 1, March 2012, Pages 25-31

https://doi.org/10.1053/j.semss.2011.11.006 Get rights and content

Lumbar total disk replacement (TDR) has been used in Europe for many years and since 2000 in the United States with the initiation of the Food and Drug Administration investigational device exemption trials. Patients enrolled in those prospective, randomized, controlled trials have now reached 5-year follow-up, the results of which are reported here for the ProDisc-L device. The follow-up rate at 5 years was 81.8% of the 236 patients randomized to either TDR or combined anterior/posterior instrumented fusion. In general, the results were stable from the 2- to 5-year follow-up periods. Both groups remained significantly improved from baseline, with noninferiority of the TDR compared with fusion being maintained. At 5-year follow-up, the range of motion of the levels treated with TDR was 7.7°. The study found that TDR and fusion are both viable treatments for chronic painful degenerative disk disease, with clinical improvements being maintained throughout the 5-year follow-up.

Section snippets

Results

Table 2 summarizes patient enrollment and follow-up. Overall patient follow-up was 97.0% of 236 patients at 2 years and 81.8% of 236 patients at 5 years. Demographics for patients enrolled and treated in the IDE study are shown in Table 3. This was an extremely well-matched cohort pair, corroborating the efficacy of the randomization paradigm. There were no statistically significant differences between the fusion and TDR patients in any of the demographics, including age, body mass index (BMI),

Discussion

The primary hypothesis of this multicenter, prospective, randomized trial was supported at both 2 years and 5 years, allowing the strong conclusion that TDR with ProDisc-L is noninferior to fusion. Although the study was not designed to show superiority, a significant difference favoring TDR was found in statistical success rates at 2 years in several parameters, such as ODI improvement, neurologic success, and radiographic maintenance of disk height.

These TDR and fusion patients who had each

Summary

A carefully selected population of highly disabled patients with mechanical DDD (failure of conservative treatment for at least 9 months with ODI >60%) were treated with circumferential spinal fusion or TDR. Not only did patients in both treatment groups experience significant improvements in measurable clinical outcomes at 2 and 5 years, but there were also substantial improvements in the functional status of these patients. Specifically, over 80% of patients in this study experienced

Conclusions

Data from the current study clearly shows that in the appropriately selected patient, spinal surgery is a very effective treatment option for predictably improving patient function while decreasing disability and pain through at least 5 years of follow-up, and is beneficial to the patient using multiple parameters for life quality. The study hypothesis was supported in that TDR surgery with ProDisc-L was demonstrated to be noninferior to fusion at 2 years, and that this benefit was maintained

Disclosure

J.E.Z. is a consultant for Synthes and Spineart and receives institutional support from Medtronic and DePuy.

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Citation Excerpt :
Patients were blinded to randomization until immediately after surgery. A comparison of the outcomes of patients prospectively randomized to ProDisc-L versus fusion has been reported at 2 years' follow-up5 and at 5 years' follow-up,6,7 but this is the first report evaluating outcomes of the 360° fusion group compared with their own failed–conservative therapy baselines. A total of 80 of the patients in whom nonoperative treatment failed were randomized to fusion and treated surgically.
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After fusion, not only did patients have significant improvements in measurable clinical outcomes such as the Oswestry Disability Index score and pain score on a visual analog scale but there were also substantial improvements in their functional status and quality of life. Specifically, over 80% of patients in this study had improvements in recreational status that was maintained 5 years after index surgery, indicating substantial improvements in life quality that were not afforded by months of conservative care. The percentage of patients using narcotics at the 5-year follow-up visit was less than half the percentage of patients who had used narcotics as part of their prior conservative treatment.
The 5-year results of this post hoc analysis of 75 patients involved in a multicenter, multi-surgeon trial support 360° fusion surgery as a predictable and lasting treatment option to improve pain and function in properly selected patients with mechanical degenerative disc disease. These improvements occurred dramatically immediately after surgery and have been maintained through the scope of this follow-up period, with 98% follow-up at 2 years and 75% of patients available at 5 years.
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Five-Year Results of the ProDisc-L Multicenter, Prospective, Randomized, Controlled Trial Comparing ProDisc-L With Circumferential Spinal Fusion for Single-Level Disabling Degenerative Disk Disease

Section snippets

Results

Discussion

Summary

Conclusions

Disclosure

Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease

Spine (Phila Pa 1976)

A revised Oswestry disability questionnaire

A prospective, randomized study of lumbar fusionPreliminary results

Spine (Phila Pa 1976)