Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2020-09-25
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Meniscal repair
Patients in need of meniscal repair
JuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.
Interventions
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JuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Nesma Bayrich, DDS
Role: STUDY_CHAIR
Zimmer Biomet
Kim Blick
Role: STUDY_CHAIR
Zimmer Biomet
Locations
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OrthoCarolina
Charlotte, North Carolina, United States
OrthoVirginia, Inc.
Richmond, Virginia, United States
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, , France
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, , Germany
Ichihara Hospital
Tsukuba, Ibaraki, Japan
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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Mathieu Thaunat, MD
Role: primary
Christain Stärke, MD
Role: primary
Tomonori Kinugasa, MD
Role: primary
Hideyuki Koga, MD
Role: primary
Other Identifiers
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CMG2017-14SM
Identifier Type: -
Identifier Source: org_study_id