JuggerStitch Post Market Clinical Follow-up Study
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Meniscal repair Patients in need of meniscal repair |
Device: JuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.
|
Outcome Measures
Primary Outcome Measures
- Clinical Success [1 year]
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 [1 year]
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events
Other Outcome Measures
- Lysholm Knee Scoring Scale [Pre-operatively, 6 weeks, 6 months and 1 year post-surgery]
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.
- Tegner Activity Level Scale [Pre-operatively, 6 weeks, 6 months and 1 year post-surgery]
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".
- International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) [Pre-operatively, 6 weeks, 6 months and 1 year post-surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
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Older than 18 years and skeletally mature;
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Willing and able to comply with the study procedures;
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Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
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Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
Exclusion Criteria:
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Meniscal tears in the avascular zone of meniscus;
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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;
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Presence of active infection;
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If female, subject is pregnant;
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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);
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The subject is unwilling or unable to give consent or to comply with the follow-up program;
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Subject meets any contraindications of the appropriate Instruction for Use.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OrthoCarolina | Charlotte | North Carolina | United States | 28207 |
| 2 | Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy | Lyon | France | 69008 | |
| 3 | Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany | 39120 | |
| 4 | Tokyo Medical and Dental University Hospital of Medicine | Tokyo | Japan | 113-8519 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Study Chair: Oliver Schätti, PhD, Zimmer Biomet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMG2017-14SM