JuggerStitch Post Market Clinical Follow-up Study

NCT04228367 | Completed Results FDA Device

• 1 other identifier: CMG2017-14SM
• Study Type: interventional
• Target: 103
• Locations: 4 countries
• Sites: 6

Brief Summary

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).

Conditions

Meniscus Tear, Tibial; Meniscus Lesion

Outcome Measures

Primary Outcomes (1)

• 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 1 year. Clinical success was defined as the absence of reoperation of the index knee due to a meniscal tear from the date of surgery through the participant's last available follow-up. All participants included in the analysis had at least 1 year of follow-up, and follow-up beyond 1 year was included when available.

  From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years

Secondary Outcomes (6)

• Number of Adverse Events

  From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years

• Lysholm Knee Scoring Scale Score

  Pre-operatively, 6 weeks, 6 months and 1 year post-surgery

• Tegner Activity Scale Score

  Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively

• International Knee Documentation Committee Subjective Knee Evaluation Form Score

  Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively

• Number of Participants by Joint Line Tenderness Test Result

  Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively

Study Arms (1)

Meniscal repair

EXPERIMENTAL

Patients in need of meniscal repair

Device: JuggerStitch Meniscal Repair Device

Interventions

JuggerStitch Meniscal Repair Device DEVICE

Treatment of torn meniscus with JuggerStitch.

Meniscal repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

OrthoVirginia, Inc.

Richmond, Virginia, 23226, United States

Location

Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy

Lyon, 69008, France

Location

Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Ichihara Hospital

Tsukuba, Ibaraki, 300-3295, Japan

Location

Tokyo Medical and Dental University Hospital of Medicine

Tokyo, 113-8519, Japan

Location

MeSH Terms

Conditions

Tibial Meniscus Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Limitations and Caveats

This was a post-market clinical follow-up study with a single-arm design and no control group. Few participants did not complete the 1-year follow-up; therefore, outcome analyses were based on available data. Race and ethnicity data were not collected.

Results Point of Contact

• Title: Nesma Bayrich, Clinical Study Manager
• Organization: Zimmer Biomet

nesma.bayrich@zimmerbiomet.com

+41793001484

Study Officials

• Nesma Bayrich, DDS

  Zimmer Biomet

  STUDY CHAIR

• Kim Blick

  Zimmer Biomet

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: September 25, 2020
• Primary Completion: April 30, 2026
• Study Completion: May 31, 2026
• Last Updated: September 24, 2026
• Results First Posted: September 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); US (2); FR (1); DE (1)