JuggerStitch Post Market Clinical Follow-up Study

JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study

This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).

Study Overview

• Status: Recruiting
• Conditions: Meniscus Lesion; Meniscus Tear, Tibial
• Intervention / Treatment: Device: JuggerStitch Meniscal Repair Device

Detailed Description

This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).

The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa To; Email: Lisa.To@zimmerbiomet.com
• Study Contact Backup: Name: Nesma Bayrich, DDS; Phone Number: +41 793001484; Email: Nesma.bayrich@zimmerbiomet.com

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
    • Contact: Mathieu Thaunat, MD
• Germany
  • Magdeburg, Germany, 39120
    • Recruiting
    • Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
    • Contact: Christain Stärke, MD
• Japan
  • Tokyo, Japan, 113-8519
    • Recruiting
    • Tokyo Medical and Dental University Hospital of Medicine
    • Contact: Hideyuki Koga, MD
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 300-3295
      • Recruiting
      • Ichihara Hospital
      • Contact: Tomonori Kinugasa, MD
• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Active, not recruiting
      • OrthoCarolina
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Active, not recruiting
      • OrthoVirginia, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
• Older than 18 years and skeletally mature;
• Willing and able to comply with the study procedures;
• Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
• Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.

Exclusion Criteria:

• Meniscal tears in the avascular zone of meniscus;
• Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
• Presence of active infection;
• If female, subject is pregnant;
• Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
• The subject is unwilling or unable to give consent or to comply with the follow-up program;
• Subject meets any contraindications of the appropriate Instruction for Use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meniscal repair; Patients in need of meniscal repair	Device: JuggerStitch Meniscal Repair Device; Treatment of torn meniscus with JuggerStitch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring of Adverse Events to confirm safety of the meniscal repair device	The safety of the system will be assessed by monitoring the frequency and incidence of adverse events	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Knee Scoring Scale	The scale is used to evaluate the outcomes of meniscus surgery. It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.	Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Tegner Activity Level Scale	The Tegner Activity Level Scale aims to provide a standardized method of grading work and sporting activities and complements Lysholm Knee Scoring Scale. The Scale is based on 10 levels with Level 10 being "Competitive Sports" and Level 0 being "Sick Leave".	Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)	The IKDC is used to measure symptoms, function, and sports activity for people with meniscal injuries. Lowest and highest (better) scores are 0 and 100, respectively.	Pre-operatively, 6 weeks, 6 months and 1 year post-surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Chair: Kim Blick, Zimmer Biomet; Study Chair: Nesma Bayrich, DDS, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Tibial Meniscus Injuries
• Other Study ID Numbers: CMG2017-14SM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No