Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device
NCT ID: NCT06899659
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
94 participants
INTERVENTIONAL
2022-02-14
2024-04-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
JuggerStitch Post Market Clinical Follow-up Study
NCT04228367
Study of Suture Repair of Torn Meniscus in the Knee
NCT02237001
SoftStitchâ„¢ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
NCT05491564
Meniscal Root Tears: Evaluation Using an Ultrahigh MRI
NCT05088525
Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome
NCT07204587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 (JuggerStitchâ„¢ 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 JuggerStitchâ„¢ 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Investigational Group
Participants in this group will receive the JuggerStitchâ„¢ Meniscal Repair Device for arthroscopic meniscal repair. The JuggerStitchâ„¢ device is a new all-inside meniscal repair system that consists of a suture device and various auxiliary tools. It is designed to repair vertical longitudinal full-thickness tears (e.g., bucket-handle) in the red-red and red-white zones of the meniscus.
JuggerStitchâ„¢ Meniscal Repair Device
Participants assigned to investigational group undergoing arthroscopy meniscal repair with JuggerStitchâ„¢ Meniscal Repair Device.
Control Group
Participants in this group will receive the Fast-Fix 360 Meniscal Repair System for arthroscopic meniscal repair. The Fast-Fix 360 is a well-established all-inside meniscal repair device that consists of a suture and two fixed rods. It is designed to repair meniscal tears in a similar manner to the JuggerStitchâ„¢ device.
Fast-Fix 360 Meniscal Repair System
Participants assigned to control group undergoing arthroscopy meniscal repair with the Fast-Fix 360 Meniscal Repair System.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JuggerStitchâ„¢ Meniscal Repair Device
Participants assigned to investigational group undergoing arthroscopy meniscal repair with JuggerStitchâ„¢ Meniscal Repair Device.
Fast-Fix 360 Meniscal Repair System
Participants assigned to control group undergoing arthroscopy meniscal repair with the Fast-Fix 360 Meniscal Repair System.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huashan Hospital
OTHER
Hunan Provincial People's Hospital
OTHER
Wuhan TongJi Hospital
OTHER
First Affiliated Hospital of Jinan University
OTHER
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shiyi Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEA2020-26SM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.