JuggerStitch Post Market Clinical Follow-up Study | NCT04228367

Studies
JuggerStitch Post Market Clinical Follow-up Study

NCT04228367

Sponsor

Zimmer Biomet

Status

Recruiting

Last Update Posted

Nov 12, 2025Actual

Enrollment

104Estimated

Phase

Not Applicable

Conditions

Meniscus Tear, Tibial
Meniscus Lesion

Interventions

JuggerStitch Meniscal Repair Device

Countries

United States
France
Germany
Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2020Actual

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Jan 10, 2020

First Submission Date that Met QC Criteria

Jan 10, 2020

First Posted Date

Jan 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2025

Last Update Posted Date

Nov 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meniscal repair	Experimental	Patients in need of meniscal repair	Device: JuggerStitch Meniscal Repair Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JuggerStitch Meniscal Repair Device	Device	Treatment of torn meniscus with JuggerStitch.	Meniscal repair

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nesma Bayrich, DDS	Contact	+41 793001484		Nesma.bayrich@zimmerbiomet.com
Lisa To	Contact			Lisa.To@zimmerbiomet.com

Overall Officials

Name	Affiliation	Role
Nesma Bayrich, DDS	Zimmer Biomet	Study Chair
Kim Blick	Zimmer Biomet	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina	Active, not recruiting	Charlotte	North Carolina	28207	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries