Abstract

Aim of the study: The purpose of this study was to assess the safety and effectiveness of Coflex Dynamic Interlaminar-Interspinous Distraction Stabilization (DIDS) device (Paradigm Spine GmbH, Germany) in treating patients with degenerative diseases of the lumbar spine (DDLS), especially lumbar canal stenosis (LCS), to confirm its indications for implantation, and to evaluate the short-term clinical outcomes of patients. Material & Methods A total of 14 patients underwent placement of a coflex implant for various lumbar degenerative indications by one neurological spine surgeon. The mean follow-up was 7.5 months. The original indications for implantation were segmental form of stenosis, mild degree of degenerative retrololisthesis, or minimal 1st degree of degenerative spondylolisthesis. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the numeric verbal ‎rating (NVR) scale for pain. Patients were asked about their satisfaction with the surgical procedure, using the validated Oswestry Disability Index Questionnaire (ODI). Follow-up radiographs were taken to determine any device-related issues. Results The most prevalent diagnoses for implantation were spinal stenosis. The mean severity of LBP decreased by 66% (from moderate to mild) at 3-month follow-up, and mostly disappear at the 1-year follow-up. Postoperatively 14 (100%) patients could walk >1000m. The ‎results of pain relief throughout the study were best at late follow-up visits. Follow-up visits did show an increase of patients satisfaction. 13 patients (93%) stated that they would undergo this surgery again. Based on the follow-up radiographs, no patients had device-related issues. Conclusion The data provided have demonstrated that the coflex implant provides pain relief in indicated DDLS cases. Despite the limitations, the current study provides evidence that immediate pain relief and increase in function can be provided by the Coflex Device with a very low rate of morbidity.