Tokyo, April 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061284) titled 'A prospective randomized trial comparing absorbable and non-absorbable sutures for postoperative neck pain after cervical laminoplasty' on April 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

Condition: Condition - Degenerative Cervical Myelopathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effects of absorbable (VICRYL USP 2) and non-absorbable (ETHIBOND USP 2) sutures used for deep layer closure in cervical laminoplasty on postoperative neck pain, nuchal ligament continuity, and imaging outcomes. The primary endpoint is neck pain at 3 months postoperatively assessed using the 0-100 mm Visual Analog Scale (VAS). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A (absorbable suture group): At the index cervical laminoplasty, polyglactin 910 (VICRYL) USP 2 will be used for closure of the deep layer, defined as the nuchal ligament and contiguous midline ligamentous/fascial complex. Deep layer closure will be performed using interrupted sutures with a standard pitch of approximately 8 mm. The subcutaneous layer will be closed with 2-0 VICRYL, and the skin will be approximated with S-S tape without skin sutures. Perioperative management will follow standard institutional practice and will be unified between groups. Interventions/Control_2 - Group B (non-absorbable suture group): At the index cervical laminoplasty, braided polyester suture (ETHIBOND) USP 2 will be used for closure of the deep layer, defined as the nuchal ligament and contiguous midline ligamentous/fascial complex. Deep layer closure will be performed using interrupted sutures with a standard pitch of approximately 8 mm. The subcutaneous layer will be closed with 2-0 VICRYL, and the skin will be approximated with S-S tape without skin sutures. Perioperative management will follow standard institutional practice and will be unified between groups.

Eligibility: Age-lower limit - 20 years-old =20 years. 3. Patients diagnosed with degenerative cervical myelopathy (primarily cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament, or cervical disc herniation) and deemed suitable for laminoplasty. 4. Patients who have provided written informed consent. 5. The standard surgical procedure is laminoplasty from C3 to C6 with or without C7 cephalic dome-like laminotomy. 6. Permitted additional procedures include caudal or ventral decompression at C2, concomitant foraminotomy, and conversion to laminectomy for up to two laminae. Key exclusion criteria - 1. Patients undergoing revision surgery. 2. Patients in whom non-degenerative conditions, such as infection, tumor, or trauma, are the primary pathology. 3. Patients in whom identification of posterior supporting structures or standardized deep layer closure is expected to be markedly difficult (e.g., due to severe scarring). 4. Patients deemed inappropriate for inclusion by the principal investigator. 5. Patients undergoing additional procedures at the laminoplasty levels, including C1 posterior arch resection, procedures involving detachment of muscles attached to C2, or resection of the C7 spinous process, as well as those requiring conversion to laminectomy involving three or more laminae. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 15 Day Date of IRB - 2026 Year 04 Month 15 Day Anticipated trial start date - 2026 Year 04 Month 20 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069803

Disclaimer: Curated by HT Syndication.