Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device
Launched by ZIMMER BIOMET · Mar 25, 2025
Trial Information
Current as of April 22, 2025
Completed
Keywords
ClinConnect Summary
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. The study will compare the clinical outcomes of the JuggerStitch™ device with the Fast-Fix 360 Meniscal Repair System, a well-established device for meniscal repair.
2. Study Design and Methodology This is a prospective, multi-center, randomized controlled pre-market clinical trial. The study will involve 5 clinical sites and will enroll a total of 94 subjects. Subjects will be randomly assigned...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
Trial Officials
Shiyi Chen, MD
Principal Investigator
Huashan Hospital
About Zimmer Biomet
Zimmer Biomet is a leading global medical technology company specializing in the design, development, and manufacturing of innovative orthopedic and surgical products. With a commitment to enhancing patient outcomes, Zimmer Biomet focuses on advancing musculoskeletal health through a broad range of solutions, including joint reconstruction, surgical instrumentation, and dental implants. The company emphasizes research and development, conducting numerous clinical trials to evaluate the safety and effectiveness of its products, while fostering collaboration with healthcare professionals to address the evolving needs of patients and providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported