Clinical Study With The Bioflex Dynamic Stabilization System In Surgical Treatment For Degenerative Lumbar Disease

ObjectiveThis study was to observe the clinical data and imaging features of Bioflexdynamic stabilization system for the treatment of degenerative lumbar diseases, inorder to explore the effects on the surgery segment and upper adjacent segment of theimPlant of Bioflex dynamic stabilization system.MethodsA total of109consecutive patients of degenerative lumbar disease underwent thestrict inclusion and exclusion criteria,28patients were treated with Bilateral Bioflexdynamic fixation(groupA),37patients underwent rigid fixation and fusion PLIF(group B),16patients received unilateral Bioflex dynamic fixation (group C)and28patients received the discectomy only(group D). The clinical efficacy was evaluatedby observing clinical data such as VAS scores, ODI scores, operative time, blood loss,Postoperative hospital days, and imaging features such as the intervertebral range ofmotion(ROM), intervertebral height and lumbar lordosis.ResultsIn group A and group B, low back pain and leg pain VAS score, ODI scores,lumbar lordosis were significantly improved at the final follow-up compared with thepreoperative(P<0.01), and the ROM of operated level were significantly reduced atthe final follow-up compared with the preoperative(P<0.01). The operative time,blood loss, Postoperative drainage from group A was less than group B (P<0.05). Theinstrumented ROM of group A was significantly better than group B at the finalfollow-up（P=0.006）. The upper adjacent segments ROM of group B was increased atthe final follow-up compared with the preoperative (P=0.041). The upper adjacentsegments ROM of group B was significantly increased than group A at the finalfollow-up. The intervertebral height ratio of group B was significantly increased at thefinal follow-up compared with the preoperative（P=0.009）. In group C and group D, low back Pain and leg pain VAS score, ODI scores,lumbar lordosis were significantly improved at the final follow-up compared with thepreoperative(P<0.01). The instrumented ROM of group D was significantly increasedat the final follow-up compared with the preoperative(P=0.003). The instrumentedROM of group C was significantly decreased at the final follow-up compared with thepreoperative(P=0.000).Conclusion1. Bilateral Bioflex dynamic fixation can obtain satisfactory clinical efficacy inthe treatment of degenerative lumbar disease In the short-term follow-up, Comparisonwith traditional PLIF, Bilateral Bioflex dynamic fixation preserves physiologicalmotion to some degree at instrumented levels without increasing the adjacent segmentROM, and have the advantages of the surgical time, blood loss, postoperativedrainage.2. Unilateral Bioflex dynamic fixation can obtain satisfactory clinical efficacy inthe treatment of degenerative disc disease(DDD), Comparison with traditionaldiscectomy, The unilateral Bioflex fixation limit instrumented segment ROM to somedegree, so reduce the risk of lumbar instability caused by decompression.