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.
Study Type
OBSERVATIONAL
Enrollment
30
Lumbar Integrated plate and spacer, with percutaneous screws and rods.
Scott & White Healthcare
Temple, Texas, United States
Radiographic fusion evaluation
Anterior Posterior / Lateral, Flexion-Extension X-rays at every timepoint will be evaluated for signs of fusion, pseudoarthrosis and implant subsidence or migration
Time frame: 2 years
Patient Self- Assessment for pain scores
VAS questionnaires to be completed at every follow-up timepoint
Time frame: 2 years
Patient Satisfaction
Questionnaire to be completed at every follow-up timepoint
Time frame: 2 years
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