PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband (NCT05690776) | Clinical Trial Compass
CompletedNot Applicable
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
France106 participantsStarted 2022-06-17
Plain-language summary
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair.
The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant \& Murley and EQ-5D-5L) at 1 year post-operative.
The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.
Who can participate
Age range
18 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 treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
. 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 ICF and has voluntarily provided written informed consent.
Exclusion criteria
. Presence of infection;
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.
What they're measuring
1
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff)
Timeframe: From operation to study completion, 0-1 year
. Insufficient blood supply or previous infections which may hinder the healing process;
. Foreign body sensitivity;
. 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.