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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

NCT06386666 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-07-19

No results posted yet for this study

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

DEVICE

Disposable fibrous ring sutures

A new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd

Sponsors & Collaborators

  • 2020 (Beijing) Medical Technology Co., Ltd

    collaborator UNKNOWN

  • Suzhou Kerui Medical Technology Co., Ltd

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-08-29
Completion
2025-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06386666 on ClinicalTrials.gov