(Newswire.net — May 14, 2015) Ione, CA — At this year’s International Society for the Advancement of Spine Surgery, 15th Annual Conference, Disc Replacement maker Spinal Kinetics presented a report on the Two Year, Multi-Center Outcomes for the Treatment of Degenerative Disc Disease in the Lumbar Spine Using a Novel, Compressible Core Prosthesis (Disc Replacement)
At the conference Dr. Ritter-Lang and his team reported significantly decreased back pain in both multi-level and single level disc replacement patients at two years.
Low back pain is one of the most prevalent problems in industrialized countries, affecting as many as 80% of all adults at some time in their lives. Among the significant contributors to low back pain is degenerative disc disease (DDD). Although fusion surgery has been well accepted for treatment of DDD, high rates of complications and stress to adjacent segments remain a concern. Lumbar total disc replacement (TDR) was developed with a goal of preserving motion and avoiding various fusion related complications.
This multi-center, single arm, prospective post-market registry of the Spinal Kinetics M6® reports on those patients who have completed at least 24 months of follow-up. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Radiographic analysis of disc angle and range of motion (ROM) was also performed.
Eighty three patients had completed their 24 month follow-up visits and a total of 121 discs were implanted in the 83 patients: forty-nine (49) patients were treated at 1 level, and 34 at multiple levels, between L2 and S1.
Paired pain scores (patients reporting ODI scores at both baseline and 24 months) was available for 80 patients and had improved significantly at 24 months. The results of the paired pain tests indicated that both multi-level and single level disc replacement groups were significantly improved at 24 months.
This is the first study to report two year clinical and radiographic outcomes of Disc Replacement using the Spinal Kinetics M6 Lumbar disc replacement implant in both single level and multi-level procedures. The results suggest significantly decreased back pain, initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease at one or more lumbar levels.
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We are now offering the breakthrough Spinal Kinetics M6 disc replacement implant for the Cervical and Lumbar spine. The first disc replacement implant to truly deserve the title “Artificial Disc”. This implant achieves the ultimate goal of replicating the healthy human disc. By providing shock absorption and graded variable motion resistance, the M6 disc replacement works in concert with the remaining human discs, to provide the best possible outcome. This “Quality of Motion” is a major benefit not available in any other disc replacement implant we have seen!