Observation of the interspinous dynamic stabilizer Coflex for the treatment of lumbar spinal stenosis for more than 10 years of follow-up
Objective To evaluate the clinical efficacy of Coflex in the treatment of lumbar spinal stenosis for more than 10 years and its effect on articular degeneration.Methods From January 2009 to June 2013,22 patients with lumbar spinal stenosis were treated with decompression combined with Coflex interspinous process dynamic stabilization,and all patients were assessed by imaging and clinical evaluation.Imaging evaluation included lumbar range of motion(ROM),intervertebral space height(ISH),intervertebral foraminal height(IFH),facet degeneration and adjacent segment degeneration(ASD)incidence;Clinical evaluation included the visual analogue scale(VAS),Owestry disability index(ODI)and Japanese orthopaedic association score(JOA)preoperatively and at the final follow-up.Procedure-related complications were recorded.Results A total of 22 patients with lumbar spinal stenosis were collected.The average age was(59.6±12.6)years(range:40-76 years).The follow-up time was 121-175 months,with an average of 156 months.VAS low back pain,VAS leg pain,ODI and JOA were improved at the last follow-up(1.82±0.98,1.64±0.81,9.09±5.39,22.82±2.93)than that preoperatively(7.36±0.67,7.09±0.70,50.45±6.46,12.82±1.33)(P<0.01).In terms of imaging evaluation,there were statistically significant differences in ISH and IFH preoperatively and postoperatively(P<0.05);but there was no significant difference between ISH and IFH at the last follow-up(P>0.05).At the last follow-up,there were statistically significant differences in ROM in the surgical segment compared with that before operation(P<0.05),but there was no significant difference in ROM in the adjacent upper and lower segments compared with the data preoperatively(P>0.05).In terms of articular degeneration,there were statistically significant differences between the adjacent upper segment and the preoperative segment at the last follow-up(P<0.05),but there was no significant difference between the surgical segment and the adjacent inferior segment compared with the preoperative segment(P>0.05).Conclusions Coflex is effective in the treatment of lumbar spinal stenosis for more than 10 years.At the same time,Coflex can effectively maintain ISH and IFH,preserve intervertebral range of motion,and effectively slow down the degeneration of facet joint in the surgical segment.