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Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device

NCT06899659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-03-28

No results posted yet for this study

Summary

This study is a prospective, multi-center, randomized controlled pre-market clinical trial in China to evaluate the safety and efficacy of the JuggerStitchâ„¢ Meniscal Repair Device for arthroscopic meniscal repair. The study aims to compare the clinical outcomes of the JuggerStitchâ„¢ device with the Fast-Fix 360 Meniscal Repair System in patients with meniscal tears. The primary endpoint is the Lysholm Knee Score at 6 months postoperatively, and secondary endpoints include immediate device success rate, Tegner Activity Score, Visual Analogue Scale (VAS) score for pain, meniscal healing evaluated by MRI, and device-related adverse event rate. The study will enroll 94 subjects across 5 clinical sites.

Conditions

  • Meniscal Tears

Interventions

DEVICE

JuggerStitchâ„¢ Meniscal Repair Device

Participants assigned to investigational group undergoing arthroscopy meniscal repair with JuggerStitchâ„¢ Meniscal Repair Device.

DEVICE

Fast-Fix 360 Meniscal Repair System

Participants assigned to control group undergoing arthroscopy meniscal repair with the Fast-Fix 360 Meniscal Repair System.

Sponsors & Collaborators

  • Huashan Hospital

    collaborator OTHER

  • Hunan Provincial People's Hospital

    collaborator OTHER

  • Wuhan TongJi Hospital

    collaborator OTHER

  • First Affiliated Hospital of Jinan University

    collaborator OTHER

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Shiyi Chen, MD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2023-10-30
Completion
2024-04-29
FDA Device
Yes

Countries

  • China

Study Locations

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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 NCT06899659 on ClinicalTrials.gov