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

NCT06899659 | Completed FDA Device

• 1 other identifier: CEA2020-26SM
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Meniscal Tears

Keywords

Meniscal Repair; Arthroscopic Surgery; JuggerStitch™ Meniscal Repair Device

Outcome Measures

Primary Outcomes (1)

• Lysholm Knee Score

  The Lysholm Knee Score is a widely used and validated tool for assessing knee function, particularly in patients with meniscal injuries. It evaluates eight aspects of knee function: limp, use of cane or crutches, locking sensation, giving way sensation, pain, swelling, climbing stairs, and squatting. Each aspect is scored on a scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function.

  Post-op 6 months

Secondary Outcomes (4)

• Immediate Device Success Rate

  Intraoperatively

• Tegner Activity Score

  Post-op 3, 6, and 12 months

• Visual Analogue Scale (VAS) Score for Pain

  Post-op 3, 6, and 12 months

• Meniscal Healing Evaluated by Magnetic Resonance Imaging (MRI)

  Post-op 6 and 12 months

Study Arms (2)

Investigational Group

EXPERIMENTAL

Participants in this group will receive the JuggerStitch™ Meniscal Repair Device for arthroscopic meniscal repair. The JuggerStitch™ 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.

Device: JuggerStitch™ Meniscal Repair Device

Control Group

EXPERIMENTAL

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 JuggerStitch™ device.

Device: Fast-Fix 360 Meniscal Repair System

Interventions

JuggerStitch™ Meniscal Repair Device DEVICE

Participants assigned to investigational group undergoing arthroscopy meniscal repair with JuggerStitch™ Meniscal Repair Device.

Investigational Group

Fast-Fix 360 Meniscal Repair System DEVICE

Participants assigned to control group undergoing arthroscopy meniscal repair with the Fast-Fix 360 Meniscal Repair System.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead
• Huashan Hospital: collaborator
• Hunan Provincial People's Hospital: collaborator
• Wuhan TongJi Hospital: collaborator
• First Affiliated Hospital of Jinan University: collaborator

Study Sites (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Study Officials

• Shiyi Chen, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: the investigational group (JuggerStitch™ Meniscal Repair Device) or the control group (Fast-Fix 360 Meniscal Repair System).

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 28, 2025
• Study Start: February 14, 2022
• Primary Completion: October 30, 2023
• Study Completion: April 29, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)