Inspan LLC has announced results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan interspinous fixation device.
In a press release, Inspan said that the device fixates the spine to allow for immediate stability, distraction, decompression, and fusion. Based on biomechanical studies, the Inspan device may be the strongest interspinous fixation device on the market and thus is being used for spinal fusion replacing the traditional method that uses pedicle screws and interbodies with laminectomies, the company said.
The clinical study was performed at the LESS Institute (Hollywood, USA) by Kingsley R Chin and co-authors Fabio Pencle and Jason Seale.
The study was a retrospective review of prospectively collected data under an IRB-approved study cohort. The study evaluated 122 surgical cases of lumbar decompression with interspinous fixation from September 2011 to October 2016. A total of 56 patients had instrumentation at L4–L5. Total female population was 46%. The median age of the patients included in the population was 50.9+/-10.7 years with a median BMI of 24.8+/-11.4 kg/m2. Two-year VAS and ODI scores showed significant improvement form 8.1+/-1.2 to 1.5+/-1.1 and 42.9+/-14.3 to 14.8+/-5.1. All surgeries were completed in less than one hour. There was a total of one revision case with removal of Inspan and converted to an open hemilaminectomy decompression.
In conclusion, the long-term outcome of the study demonstrated improved outcomes in patients who underwent interspinous distraction decompression in an ambulatory surgery centre using the Inspan device at L4-L5 for degenerative spinal stenosis. No complications or implant failures were reported.