Clinical Research On The IN-Space Interspinous Process Distraction System For The Treatment Of Lumbar Spinal Stenosis

Objective Evaluate the curative effect and safety of Lumbar Spinal Stenosis treated by IN-SPCAE interspinous process distraction system. Provide medical evidence for clinical treatment and offer new mentality to the treatment of Lumbar Spinal StenosisMethods The theoretical part based on the research of ancient and modern literature, discusses knowledge of the Lumbar Spinal Stenosis, etiology and treatment of disease in traditional Chinese medicine, and knowledge of Lumbar Spinal Stenosis; conclusion and review of the recent advances in the treatment in western medicine.Clinical studies adopt self control, a single-center, parallel controlled, no-random design scheme in clinical test.23patients with Lumbar Spinal Stenosis were collected in clinic, and were divided into two groups, llpaients in treatment group and12patients in control group. Patients in the treatment group were treated by IN-SPCAE interspinous process distraction system, and the control group treated by Microendoscopic discectomy. Compare the two groups with Japanese Orthopaedic Association Scores (JOA), Visual Analog Scale(VAS)and the symptoms changes, then evaluate effectiveness of treatments and the differences between two groups and evaluate the effect of pain relieve and the quality of neck. Three months after treatment, referring to the standard of William’s efficacy, evaluate the final efficacy of two groups.Results In the clinic study, the score of JOA and VAS were better than before the treatment in both groups. About VAS scores:1week after treatment, patient in treatment group were better than in control group, the difference was significant(P<0.01);1month after treatment, patient in treatment group were slightly better than in control group, the difference had statistical significance(P<0.05),3months after treatment, VAS scores between two groups had no statistical significance(P>0.05).About JOA scores:1week after treatment, patient in treatment group were better than in control group,the difference was significant(P<0.01);1month after treatment, patient in treatment group were slightly better than in control group, the difference had statistical significance(P<0.05);3months after treatment, NDI scores between two groups had no statistical significance(P>0.05).Based on the standard of William’s efficacy,3months after treatment,90.9%of patients showed excellent or good outcomes in treatment group, but75%of patients showed excellent or good outcomes in control group.Conclusion IN-SPCAE interspinous process distraction system is safe, simple in operation and has excellent short-term curative effect. It can dispel or relieve symptom at once, such as lumbocrural pain and intermittent claudication. Besides it has low recurrence rate.