JuggerStitch Post Market Clinical Follow-up Study

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228367
• Other study ID #: CMG2017-14SM
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: Elliott Goff, PhD
• Phone: 0041 79 222 23 08
• Email: elliott.goff[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meniscus Lesion
• Meniscus Tear, Tibial
• Tibial Meniscus Injuries

Intervention

Device:
• JuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.

Locations

Country	Name	City	State
France	Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy	Lyon
Germany	Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg	Magdeburg
Japan	Tokyo Medical and Dental University Hospital of Medicine	Tokyo
Japan	Ichihara Hospital	Tsukuba-shi	Ibaraki-ken
United States	OrthoCarolina	Charlotte	North Carolina
United States	OrthoVirginia, Inc.	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  France,  Germany,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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