A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal

The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.

NCT Number	NCT06386666
Lead Sponsor	Suzhou Care-Real Medical Technology Co., Ltd. Collaborators: 2020 (Beijing) Medical Technology Co., Ltd
Conditions	Intervertebral Disc Disorder
Enrollment	135 participants
Start Date	2024-08-15
Primary Completion	2025-08-29 (estimated)
Study Completion	2025-11-15 (estimated)
Updated on ClinicalTrials.gov	2024-07-19