Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT06899659
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 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.
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. 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.
Study:
NCT06899659
Study Brief:
Protocol Section:
NCT06899659