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Latest result of research on use of interlaminar distractor Coflex in spinal disease
International Society for the Advancement of Spine Surgery, 21-23 March 2012
During the Meeting of International Society for the Advancement of Spine Surgery ISASS (21-23 March 2012), a number of researchers reported the latest result of research on use of interlaminar distractor Coflex in spinal disease.
Dr. Joshua Auerbach, from New York USA, won the 2012 Kostiuk Innovation Award by presenting the paper “Coflex® Interlaminar Stabilization Compared to Posterior Spinal Fusion for Spinal Stenosis and Spondylolisthesis: Two-year Results from the Prospective, Randomized, Multicenter Food and Drug Administration IDE Trial” This multi-center study perform in 21 centers the USA under the supervision of USA FDA, recurred 219 patients suffering from back pain because of moderate spinal stenosis or low grade spondylolisthesis. There patients were randomly treated by either the newer method of “Coflex Interlaminar Stabilization” (146 patient) or by the standard method of “posterior spinal fusion” (73 patients). Traditionally, the patients with back pain with spinal stenosis or spondylolisthesis are treated with lumbar spinal fusion, i.e. two neighboring pieces of lumbar vertebrae are permanently fixed together. On the other hand, the newer method of “Coflex Interlaminar Stabilization” apply dynamic distraction between two pieces of vertebra to reduce pressure on the affected lumbar intervertebral disc and facet joint. The movement between the two pieces of vertebrae were maintained. The result of the study showed, the group of patient treated with Coflex had significantly shorter operation time, shorter hospital stay, less blood loss during the peri-operative period. After at least two years of follow-up, both group of patient improved, but the group of patient treated with Coflex has significantly less back pain and leg pain (lower VAS and ODI score). The overall success rate according to the stringent FDA criteria was higher for the Coflex group (66.4%) as compared to the spinal fusion group(59.7%). Moreover, at the level above the operation level, normal movement is maintained in the patient treated with Coflex. But, in the lumbar spinal fusion group, there are significantly more angle of movement (3.8 Vs 6.4 deg)and translation (0.78 Vs 1.15 mm) on the adjacent level; indicating increased stress on the adjacent level. There are more patients in the spinal fusion group that needed surgery of the adjacent level as compared to the Coflex group. The study showed Coflex is the safe, effective and non-inferior treatment as compared to posterior spinal fusion using pedicle screw fixation for similar patients suffering from lumbar spinal stenosis or low grade spondylolisthesis. Insertion of Coflex as compared to lumbar spinal fusion can reduce the need for surgery on the adjacent level.
In there ISASS 2012 meeting, Dr. R. Bertagonli from Straubing, Germany also reported 170 patients with spinal stenosis or low grade spondylolisthesis treated with Coflex. The age ranged from 35 to 86 years old. Among the patients, 122 patient received single level treatment: L2/3 (4%), L3/4 (22.2%), L4/5 (71.4%), L5/S1 (2%). 48 patients received more than one level Coflex. The level affected including L2/3-L3/4 (26.7%), L3/4-L4/5 (67.3%), L4/5-L5/S1 (2%), L4/5-L5/L6 (2%) and L2-L3 (2%). 87% of the patients were satisfied with result at 12 months and 24 months after surgery. All patients who were follow-up till 36 month and 48 months after surgery reported satisfaction of the result.
Summary of results of reports from both USA and Europe and some other other regions, showed Coflex is an safe and effective treatment of patients with lower back pain associated with spinal stenosis or low grade spondylolisthesis. The result is better than lumbar spinal fusion using pedicle screws and the benefit are long lasting.