The clinical trial is prospective, randomized, controlled, multi-center trial comparing decompression alone to decompression with coflex Interlaminar Stabilization to treat severe lumbar spinal stenosis. A total of 225 patients were enrolled in the study at seven sites throughout Europe with 91 percent follow-up at two years.
Here are five study insights:
1. Patients in the coflex group experience higher composite clinical scores, 0.017, as compared to the decompression alone group.
2. Decompression alone patients reported more loss of foraminal and posterior disc height maintenance compared to the coflex group.
3. Patients in the decompression alone group had 228 percent more subsequent epidural steroid injections than the coflex group.
4. Coflex patients reported 2.4 times more improvement in walking distance measurements.
5. At the two-year follow up, the decompression alone group was 1.4 times more likely to be using opioids.
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