Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip (NCT03985839) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
United States298 participantsStarted 2019-08-01
Plain-language summary
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 315 subjects needing reattachment of soft tissue to bone.
Who can participate
Age range
12 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 requires reattachment of soft tissue to bone for one of the following indications:
. Subject if ≥ 18 years of age or legally authorized representative if subject is \<18 years of age has consented to participate in the study by signing the IRB approved informed consent form. If \<18 years of age, subject has assented to participate in the study by signing the IRB approved assent form.
. Subject is ≥12 years of age at time of surgery.
. Willing and able to make all required study visits.
. Able to follow instructions.
Exclusion criteria
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.
. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
. Comminuted bone surface, which would compromise secure anchor fixation.
. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
. The presence of infection.
. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
. Currently using tobacco products (cigarette, smokeless tobacco, e-cigarettes, vaping etc.).