Stopped: Sponsor has elected to place the Tapestry RC PMCF study on hold. The Tapestry RC product line is being enhanced, and we have chosen to delay data collection on this product until the new devices are available. Study is anticipated to resume in 2026.
United States170 participantsStarted 2026-12-28
Plain-language summary
The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor.
Who can participate
Age range
21 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
. Adult, 21 years and older;
. Patient with a diagnosis of a symptomatic primary partial-thickness or full-thickness tear of the supraspinatus and/or infraspinatus tendons amenable to repair that meets one of the following criteria:
. Patient is able and willing to complete the protocol required follow-up;
. Patient is able and willing to sign the IRB approved informed consent;
. Independent of study participation, patient qualifies for arthroscopic rotator cuff repair and meets the approved indications for use of the commercially available Tapestry RC Biointegrative Implant System
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.
What they're measuring
1
Re-tear rate after arthroscopic rotator cuff repair
. Hypersensitivity to bovine-derived materials or poly(D,L-lactide) materials;
. Patient with an irreparable or partially reparable rotator cuff tear;
. Revision rotator cuff repair;
. Off-label use of the study device;
. Patient is known to be pregnant or nursing;
. Patient is a prisoner;
. Patient is a known alcohol or drug abuser;
. Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that will not allow for proper informed consent or compliance with study requirements;