Evaluating the Topping-off Surgery Technique for Treating Lumbar Degenerative Disease Comparing It With Traditional Lumbar Fusion Surgery in Adults

What this Trial Is About

Lumbar degenerative disease commonly affects middle-aged and elderly individuals and those who sit for prolonged periods, causing lower back pain, stiffness, and numbness in the legs. Researchers are evaluating the Topping off technique, a new treatment combining interbody fusion and dynamic fixation, to see if it can reduce pressure on affected discs, promote repair, and preserve some lumbar spine movement. This study compares the Topping off method with traditional two-stage fusion surgery in patients with degenerative lumbar diseases at the L4-5 and L5-S1 spinal segments. The study involves two groups one receiving the Topping off technique, which includes posterior lumbar interbody fusion PLIF combined with Wallis interspinous dynamic fixation device implantation, and the other treated with standard lumbar fusion surgery. Both groups consist of patients who underwent surgery for continuous double segment lumbar degenerative diseases. Follow-up occurs before and after surgery, with an average period of 24 months, to assess treatment effects. Participants will be evaluated using the Oswestry Disability Index ODI, Pain Visual Analog Scale VAS, and Japanese Orthopaedic Association JOA lumbar spine function score to measure clinical outcomes. Imaging tests like X-rays and MRIs will assess lumbar range of motion, device segment mobility, intervertebral disc height, and nucleus pulposus signal intensity. The primary outcomes include pain, function scores, and spinal alignment angles measured over two years. The study is randomized and quadruple-blinded, led by Qianfoshan Hospital.

Study on Topping-off Technique for Treating LDD