Clinical Trial: Necessity of lumbar corset use after full-endoscopic spine surgery for lumbar spinal stenosis: a prospective randomized non-inferiority trial using early postoperative Oswestry Disability Index as the primary endpoint (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061577) titled 'A prospective randomized trial comparing lumbar corset use versus no corset after full-endoscopic spine surgery for lumbar spinal stenosis' on May 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

Condition: Condition - Lumbar spinal stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether postoperative management without a lumbar corset is non-inferior to management with a lumbar corset after FESS decompression for lumbar spinal stenosis, with respect to the Oswestry Disability Index (ODI) at 6 weeks postoperatively. The primary endpoint is the ODI at 6 weeks postoperatively (0-100 points). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A (lumbar corset group): After FESS decompression for lumbar spinal stenosis, patients will wear a lumbar corset for 6 weeks postoperatively. The method of corset use will follow routine clinical practice at the institution. Surgical procedures, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups. No additional examinations will be performed solely for research purposes. Interventions/Control_2 - Group B (no corset group): After FESS decompression for lumbar spinal stenosis, patients will not wear a lumbar corset. Surgical procedures, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups. No additional examinations will be performed solely for research purposes.

Eligibility: Age-lower limit - 20 years-old =20 years. 3. Patients with degenerative lumbar spinal stenosis involving one or two levels, without apparent instability, and deemed suitable for decompression alone. 4. Patients who have provided written informed consent. Key exclusion criteria - 1. Patients undergoing revision surgery. 2. Patients in whom non-degenerative conditions, such as infection, tumor, trauma, or deformity, are the primary pathology. 3. Patients with apparent instability, degenerative spondylolisthesis, or other conditions requiring concomitant fusion surgery. 4. Patients deemed inappropriate for inclusion by the principal investigator. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 29 Day Date of IRB - 2026 Year 05 Month 14 Day Anticipated trial start date - 2026 Year 05 Month 14 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070368

Disclaimer: Curated by HT Syndication.