Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transp… (NCT04903106) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
United States, Australia, France63 participantsStarted 2022-01-20
Plain-language 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 use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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;
Exclusion criteria
✕. 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;
✕. 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);