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 range
16 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. 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);