NCT06386666

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

A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Suzhou Care-Real Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intervertebral Disc Disorder

Interventions

Type	Name	Description
DEVICE	Disposable fibrous ring sutures	A new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-08-29
• Completion: 2025-11-15
• First posted: 2024-04-26
• Last updated: 2024-07-19