Clinical Trial: A Prospective Randomized Controlled Trial Evaluating the Necessity of Postoperative Cervical Collar Use After Anterior Cervical Fusion Using ROI-C, With Early Postoperative Neck Disability Index as the Primary Outcome (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061575) titled 'A prospective randomized trial of cervical collar use after anterior cervical discectomy and fusion using ROI-C' 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 - Degenerative cervical myelopathy and/or radiculopathy (primarily including cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament, and cervical disc herniation). Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effect of wearing a Philadelphia cervical collar for 6 weeks versus no routine cervical collar on early postoperative neck disability after one- or two-level anterior cervical discectomy and fusion (ACDF) using ROI-C. The primary endpoint is the Neck Disability Index (NDI, 0-50 points) at 6 weeks postoperatively. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A (cervical collar group): After one- or two-level ACDF using ROI-C, patients will wear a standard Philadelphia cervical collar for 6 weeks postoperatively. ROI-C manufactured by Highridge Medical will be used as the stand-alone cervical fixation device, without an additional anterior plate. Surgical approach (left transverse cervical incision), wound closure, drain use, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups as much as possible. Interventions/Control_2 - Group B (no cervical collar group): After one- or two-level ACDF using ROI-C, patients will not routinely wear a cervical collar postoperatively. ROI-C manufactured by Highridge Medical will be used as the stand-alone cervical fixation device, without an additional anterior plate. Surgical approach, wound closure, drain use, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups as much as possible. If the attending physician judges that collar use is necessary for safety or clinical reasons, cervical collar use will be allowed and recorded as a post-randomization management change.

Eligibility: Age-lower limit - 20 years-old =20 years 3. Patients with one- or two-level degenerative cervical myelopathy and/or cervical radiculopathy (mainly cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament, cervical disc herniation, etc.) who are deemed suitable for anterior cervical fusion 4. Patients who have provided written informed consent Key exclusion criteria - 1. Revision surgery cases 2. Patients whose primary pathology is non-degenerative disease, such as infection, tumor, or trauma 3. Fusion involving three or more levels 4. Patients judged unsuitable for study participation by the operating surgeon because of poor bone quality or other clinical reasons Target Size - 56

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 26 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=R000070329

Disclaimer: Curated by HT Syndication.