Background: Low back pain is one of the most prevalent problems in industrialized countries and often results in decline in the quality of life of the affected individuals. There are a number of contributors to low back pain, one of which is Degenerative Disc Disease (DDD) of the spine. Although fusion has been well accepted for the treatment of DDD, high rates of complications and stress to adjacent segments remain a concern. Iumbar Total Disc Replacement (lTDR) is one technology that has become popular as an alternative to fusion. Artificial disc replacements were developed with a goal of preserving motion and avoiding various fusion-related complications.
Methods: This is a multi-center, single arm, prospective post-market registry of the M6®-L, a compressible core TDR, consisting of consecutive patients presenting with lumbar DDD who agreed to participate. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Data was collected pre-operatively, peri-operatively and post-operatively at 6 weeks, 3, 6 and 12 months and yearly thereafter. AP, Lateral and flexion/extension x-rays were performed for radiographic analysis. Patients are monitored continuously to track complications.
Results: Results for 45 patients, (20 males, 25 females, mean age 44.6 years) are reported. Thirty-one patients were treated at 1 level, and 14 at multiple levels, between L3 and S1. Mean ODI has decreased significantly (p<0.001) from 45.9 ± 16.5% at baseline to 19.7 ± 19.3 at 2 years post-implant. Low back pain has also decreased significantly (p<0.001) from baseline with a preoperative back pain VAS of 7.0 and a 2 year value of 2.5. Physiologic range of motion was maintained from baseline through 2 years.
Conclusions: Two year results from the post-market registry suggest initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease.PDF
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