Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060881) titled 'Predicting Dural Adhesion Before First-Time Spinal Surgery Using Preoperative Imaging' on March 21.

Study Type: Observational

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

Condition: Condition - Spinal surgery involving direct decompression with exposure of the dura mater Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the association between preoperative MRI (including axial T1-weighted images) and CT findings and the intraoperative dural-ligamentum flavum adhesion, and to optimize surgical strategies such as surgical approach, dissection technique, surgeon allocation, and preoperative risk explanation. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria: 1. Patients undergoing spinal surgery (cervical, thoracic, or lumbar) at our institution, including endoscopic decompression, open decompression, and direct decompression performed with fusion procedures. 2. At least one intervertebral level in which the dura mater is exposed intraoperatively and the ligamentum flavum (or surrounding tissues) is dissected from the dura. 3. The target intervertebral level must not be a revision site (no previous surgery at the same level). Cases may be included even if other levels in the same operation are revision sites, provided that the target level is a primary surgery site. 4. Preoperative MRI (including axial T1-weighted images) and CT obtained as part of routine clinical care at our institution. Key exclusion criteria - Patients (or intervertebral levels) meeting any of the following criteria will be excluded: 1. Revision surgery at the same intervertebral level. 2. Fusion procedures intended only for indirect decompression (e.g., cases or levels in which direct decompression exposing the dura mater is not performed). 3. Conditions in which the mechanism of adhesion formation differs substantially from that of typical degenerative disease, such as infection, tumor, trauma, or inflammatory disorders. 4. Preoperative imaging not suitable for evaluation. 5. Refusal of participation in the study by the patient (or legally authorized representative). Target Size - 2000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 03 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 03 Month 22 Day Last follow-up date - 2031 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069651

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