Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04228367
Other study ID # CMG2017-14SM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT03479775 - Muscle Function and Traumatic Knee Injury in Sports
Recruiting NCT05882591 - Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment N/A
Recruiting NCT05322005 - Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides N/A
Recruiting NCT04436523 - Blood Flow Restriction After Meniscus Repair N/A
Completed NCT05370937 - Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears N/A
Recruiting NCT06159153 - Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy N/A
Completed NCT01254825 - The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy Phase 4
Recruiting NCT04153643 - Meniscus Surgery Registry
Completed NCT03966638 - Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal Injection of Platelet-rich Plasma (PRP)
Not yet recruiting NCT03490799 - Muskloskeletal Ultrasound Versus Magnetic Resonance Imaging in Meniscal Abnormalities
Recruiting NCT06376422 - Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss N/A
Recruiting NCT05261360 - Clinical Efficacy of Exosome in Degenerative Meniscal Injury Phase 2
Recruiting NCT04607538 - The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.
Completed NCT05048420 - THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION N/A
Completed NCT04921202 - Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function
Recruiting NCT03968029 - Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Avascular Area N/A
Not yet recruiting NCT05505747 - Enhancing Recovery Through a Combined Mechanobiologic Intervention Following Meniscus Repair Phase 2/Phase 3
Withdrawn NCT01991353 - Platelet Rich Plasma Study With Meniscal Repair N/A
Completed NCT02322372 - Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy Phase 4
Completed NCT04129827 - Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction