Posterior Device Fixation Using Pedicle Screws in Patients with Degenerative Spine Disease: A Prospective, Single-Group, Therapeutic Pilot Study

Abstract

Study Design Prospective study.

Objectives To evaluate the effectiveness and safety of posterior interbody fusion with a new type of pedicle screws after posterior decompression for degenerative spinal disease.

Summary of Literature Review There are no reports of surgical treatment results using the new type of pedicle screw (LumFix™) analyzed herein. We report the results of posterior interbody fusion with this new type of pedicle screw.

Materials and Methods Ten patients underwent surgical treatment for degenerative spinal disease and were followed up for at least 1 year. In all cases, fixation using pedicle screws and posterior interbody fusion were performed after posterior decompression. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were measured before surgery, at 3 months postoperatively, and at 12 months postoperatively. Bone union was investigated through simple radiographs and computed tomography (CT) at 12 months postoperatively. In addition, blood inflammation levels and basic vital signs were investigated preoperatively and at the last follow-up.

Results In all cases, preoperative symptoms improved, and the back pain VAS improved from 7.30±1.49 preoperatively to 2.70±1.64 at 3 months postoperatively and 1.80±1.40 at the final follow-up. Leg pain was 7.40±1.17 preoperatively and 2.60±2.17 at 3 months postoperatively. At the last follow-up, it improved to 2.40±1.96 (p<0.001). The ODI improved from 28.80±4.89 preoperatively to 15.60±5.04 at 3 months postoperatively and 16.90±6.61 (p=0.002) at the final follow-up. Bone union was achieved in all cases. Inflammation levels and vital signs were within the normal range both preoperatively and at 12 months postoperatively.

Conclusions The LumFix™ pedicle screws used in this study were fused in 100% of patients with degenerative spinal diseases. No complications were observed, and the VAS of back and leg pain and ODI of the lumbar spine significantly improved. There were no abnormal findings in blood tests or vital signs, demonstrating biocompatibility. Therefore, the type of new pedicle screw analyzed in this study can be used in fusion surgery for degenerative spinal diseases.