Status:
COMPLETED
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Meniscus Tear
Eligibility:
All Genders
16-70 years
Brief Summary
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for ...
Detailed Description
This PMCF study is to satisfy the post-market surveillance obligations to the European Medical Device Regulation (EU MDR 2017/745). The data collected will serve the purpose of confirming the safety a...
Eligibility Criteria
Inclusion
- Meniscal Repair
- Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
- Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
- Subject requires a meniscal repair;
- Subject is suitable to participate in the study in the opinion of the Investigator;
- Subject requires a meniscus repair concerning the red-red or red-white zones for acute or chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate ligament (ACL) reconstruction.
- Meniscal Allograft Transplantation
- Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
- Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
- Subject requires a meniscal allograft transplantation;
- Subject is suitable to participate in the study in the opinion of the Investigator.
- Subject requires a MAT for symptomatic meniscal insufficiency (load-related pain and swelling in the compartment post meniscectomy) for which conservative treatment has failed, with or without cartilage repair or restoration (including ACL reconstruction or repair).
- Meniscal Repair
Exclusion
- Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation;
- Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
- Women who are pregnant or nursing;
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative);
- Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
- Patients with irreparable meniscal tears (i.e. multiple tears);
- Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious defects;
- Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury);
- Performance of a significant concomitant procedure, specifically a cartilage repair or restoration (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
- History of ipsilateral knee surgery, septic joint, or fracture;
- Pathological conditions in the soft tissue that would prevent secure fixation of the device;
- Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
- The presence of infection;
- Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
- Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
- Patients who have an Ahlback grade greater than II;
- Patients with a body mass index larger than 35;
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Meniscal Allograft Transplantation
Key Trial Info
Start Date :
January 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 26 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04903106
Start Date
January 20 2022
End Date
November 26 2024
Last Update
December 13 2024
Active Locations (5)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Hospital for Special Surgery
New York, New York, United States, 10021
3
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
4
Ambroise Paré Clinic
Paris, Neuilly-Sur-Seine, France, 92200