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

A Prospective Multi-Center, Randomized Controlled Pre-Market Clinical Trial to Assess the Safety and Effectiveness of the JuggerStitch™ Meniscal Repair Device for Arthroscopic Meniscal Repair

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 meniscal repair. The study aims to compare the clinical outcomes of the JuggerStitch™ 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.

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 to either the investigational group (JuggerStitch™ device) or the control group (Fast-Fix 360 device). The primary endpoint is the Lysholm Knee Score at 6 months postoperatively, and secondary endpoints include immediate device success rate, Tegner Activity Score, VAS score for pain, meniscal healing evaluated by MRI, and device-related adverse event rate.
3. Inclusion and Exclusion Criteria 1) 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.

2) 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;

4. Surgical Procedure The surgical procedure will involve arthroscopic exploration and repair of the meniscal tear using either the JuggerStitch™ device or the Fast-Fix 360 device. The specific steps for each device will be followed according to the manufacturer's instructions and the surgeon's standard operating procedures.

Postoperative Rehabilitation and Follow-up: Postoperative rehabilitation will include the use of an elastic bandage, appropriate massage to prevent blood clots, and guidance on quadriceps isometric contraction and straight leg-raising training. Subjects will be followed up at 3 months, 6 months, and 12 months postoperatively. At each follow-up visit, the Lysholm Knee Score, Tegner Activity Score, and VAS score for pain will be recorded. MRI of the knee joint will be performed at 6 months and 12 months postoperatively to evaluate meniscal healing.

Assessment of Efficacy and Safety: Efficacy will be assessed using the Lysholm Knee Score, Tegner Activity Score, and VAS score for pain. Safety will be assessed by monitoring and recording adverse events, including device-related adverse events, during the follow-up period.

Statistical Considerations: The sample size calculation is based on the difference in Lysholm Knee Score at 6 months postoperatively. A total of 94 subjects will be enrolled, with 47 subjects in each group. The primary endpoint will be analyzed using a covariance analysis model, and the secondary endpoints will be analyzed using appropriate statistical methods.

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