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

Launched by ZIMMER BIOMET · Mar 25, 2025

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