Status:
COMPLETED
Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Huashan Hospital
Hunan Provincial People's Hospital
Conditions:
Meniscal Tears
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study is a prospective, multi-center, randomized controlled pre-market clinical trial in China to evaluate the safety and efficacy of the JuggerStitch™ Meniscal Repair Device for arthroscopic men...
Detailed Description
1. Purpose of the Study The purpose of this study is to evaluate the safety and efficacy of the JuggerStitch™ Meniscal Repair Device for arthroscopic meniscal repair in patients with meniscal tears. T...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years
- Scheduled for meniscal repair with a vertical longitudinal full-thickness tear (e.g., bucket-handle) in the red-red and red-white zones
- Able to understand all risks and benefits described in the informed consent form and willing to comply with the rehabilitation and follow-up visits specified in the clinical trial protocol
Exclusion
- Meniscal tears in the avascular zone of the meniscus
- Meniscal tears not suitable for repair due to the degree of damage (marked irregularity and complex tearing) to the meniscus body, including degenerative, radial, horizontal cleavage, flap, and root tears
- Multiple ligament injuries of the affected knee joint
- Adhesion of the affected knee joint
- Planned intraoperative or postoperative intra-articular injection
- Articular surface cartilage injury of the targeted knee assessed by the - International Cartilage Repair Society (ICRS) is grade 3-4 Kellgren-Lawrence grades of documented radiographic evidence of osteoarthritis (OA) in the affected knee is ≥III
- Instability or valgus/varus deformity (\>5°) of the affected knee
- Acute or chronic, local or systemic infections
- Metabolic diseases
- Abnormal liver and kidney function (creatinine 3 times higher than the upper limit of normal value or alanine aminotransferase or aspartate aminotransferase 3 times higher than the upper limit of normal value) before operation
- History of operation in the affected knee
- Acute myocardial infarction or stroke occurred within 6 months before operation
- Known allergy to any material (polyethylene, polypropylene, polyester, polyetheretherketone) of the implants
- Pregnant or known to be pregnant
- Other circumstances that the researchers believe may affect the efficacy and safety evaluation of the investigated medical devices
- Currently participating in other clinical trials
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06899659
Start Date
February 14 2022
End Date
April 29 2024
Last Update
March 28 2025
Active Locations (2)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
2
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040