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JuggerStitch Post Market Clinical Follow-up Study

Primary Purpose

Meniscus Tear, Tibial, Meniscus Lesion

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
JuggerStitch Meniscal Repair Device
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Tear, Tibial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OrthoCarolinaRecruiting
  • OrthoVirginia, Inc.Recruiting
  • Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique SantyRecruiting
  • Medizinische Fakultät der Otto-von-Guericke-Universität MagdeburgRecruiting
  • Ichihara HospitalRecruiting
  • Tokyo Medical and Dental University Hospital of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meniscal repair

Arm Description

Patients in need of meniscal repair

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2020
Last Updated
September 4, 2023
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT04228367
Brief Title
JuggerStitch Post Market Clinical Follow-up Study
Official Title
JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tear, Tibial, Meniscus Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meniscal repair
Arm Type
Experimental
Arm Description
Patients in need of meniscal repair
Intervention Type
Device
Intervention Name(s)
JuggerStitch Meniscal Repair Device
Intervention Description
Treatment of torn meniscus with JuggerStitch.
Primary Outcome Measure Information:
Title
Clinical Success
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Monitoring of Adverse Events to confirm safety of the meniscal repair device
Description
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Lysholm Knee Scoring Scale
Description
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.
Time Frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Title
Tegner Activity Level Scale
Description
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".
Time Frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Title
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Description
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.
Time Frame
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elliott Goff, PhD
Phone
0041 79 222 23 08
Email
elliott.goff@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa To
Email
Lisa.To@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Goff, PhD
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Chair
Facility Information:
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott O'Neal, Dr
Facility Name
OrthoVirginia, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Lawhorn
First Name & Middle Initial & Last Name & Degree
Keith Lawhorn
Facility Name
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Thaunat, MD
Facility Name
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christain Stärke, MD
Facility Name
Ichihara Hospital
City
Tsukuba-shi
State/Province
Ibaraki-ken
ZIP/Postal Code
300-3295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomonori Kinugasa, MD
Facility Name
Tokyo Medical and Dental University Hospital of Medicine
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideyuki Koga, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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JuggerStitch Post Market Clinical Follow-up Study

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