Tokyo, May 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061648) titled 'A comparative study of posterior supporting tissue injury between uniportal and biportal full-endoscopic lumbar decompression' on May 21.

Study Type: Observational

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

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

Objective: Narrative objectives1 - The objective of this study is to compare changes in the cross-sectional area of the multifidus muscle from preoperative MRI to approximately 6 months after surgery between uniportal and biportal full-endoscopic lumbar decompression for lumbar spinal stenosis, and to clarify the degree of posterior supporting tissue injury associated with each surgical technique. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients undergoing one- or two-level full-endoscopic lumbar decompression for lumbar spinal stenosis, mainly due to degenerative disease, at our hospital. 2. Patients undergoing either uniportal or biportal full-endoscopic lumbar decompression. 3. Patients aged 20 years or older at the time of surgery. 4. Patients who undergo preoperative MRI and MRI approximately 6 months after surgery and in whom the cross-sectional area of the multifidus muscle can be evaluated. 5. Patients who undergo postoperative CT at 1-2 days, postoperative MRI at 3-4 days, MRI approximately 6 months after surgery, and routine clinical symptom assessment according to the clinical pathway of our hospital. Key exclusion criteria - 1. Patients whose main pathology is not lumbar spinal stenosis, such as tumor, infection, trauma, or inflammatory disease. 2. Patients undergoing concomitant fusion surgery. 3. Patients undergoing decompression at three or more levels. 4. Patients with a history of previous surgery at the target level. 5. Patients who cannot undergo preoperative MRI or MRI approximately 6 months after surgery due to contraindications to MRI or other reasons. 6. Patients in whom image assessment is technically difficult due to severe artifacts, inconsistent imaging range, or other reasons. 7. Patients who refuse the use of their information through the opt-out process. 8. Patients judged by the principal investigator to be inappropriate for this study. Target Size - 140

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 10 Day Date of IRB - 2026 Year 05 Month 20 Day Anticipated trial start date - 2026 Year 05 Month 20 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070378

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