Degenerative Disc Disease Clinical Trial
Official title:
Circumferential Lumbar Spinal Fusion for Treatment of Degenerative Disc Disease: A Prospective, Non-Randomized Clinical Study
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.
A total of thirty subjects will be enrolled at Scott & White Healthcare. The INDEPENDENCE
spacer will be filled with autogenous bone graft material. The devices subject to this
Agreement have received 510(k) clearance from the FDA for the indications specified in this
Agreement.
Patients will be followed for 2 years with evaluations at the following time intervals:
preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6
months, 12 months, and 24 months.
;
Observational Model: Case-Only, Time Perspective: Prospective
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