Efficacy of Wallis interspinous dynamic stabilization implant in the treatment of primary lumbar disc herniation: A prospective randomised controlled trial

Abstract

Purpose:To investigate the efficacy of Wallis implant after lumbar discectomy compared with discectomy alone for patients with primary lumbar disc herniation.Methods: A total of 77 patients with primary lumbar disc herniation were randomly assigned to receive posterior lumbar discectomy combined with (n =40, Wallis group) or without (n =37, control group) Wallis implantation. The primary outcomes were Visual Analogue Scale (VAS), Japanese Orthopedics Association (JOA) score and Oswestry Disability Index (ODI). The secondary outcomes were intervertebral disc height (DH), range of motion (ROM) of operated segments, complications and the time of surgery.Results: No significant difference was found between the two groups for the VAS, JOA and ODI scores at 1 week after treatment (P>0.05). Wallis group had better scores than that for control group at 12 months (P<0.05) and last follow-up time (P<0.05). Wallis group had higher DH than that for the control group at each follow-up moment (P<0.001).Conclusion: Combination treatment may provide benefits comparable to lumbar discectomy alone for patients with lumbar disc herniation by restoring the intervertebral disc height and preserving limited motion of the spine