New shoulder implant aims to cut Re-Tear rates after rotator cuff surgery
NCT ID NCT06287853
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special implant called TAPESTRY that is placed during shoulder surgery to support healing of torn rotator cuff tendons. About 170 adults with partial or full-thickness tears will receive the implant and be followed for 6 months. The main goal is to see if the implant lowers the chance of the tendon tearing again, as seen on MRI scans.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will include both males and females undergoing arthroscopic rotator cuff repair due to partial or full-thickness tears of the supraspinatus and/or infraspinatus tendon.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult, 21 years and older; 2. 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: * Partial-thickness tear planned for standalone treatment (no surgical repair with sutures/suture anchors) with the Tapestry Biointegrative Implant, or * Full-thickness tear planned for treatment with the Tapestry Biointegrative Implant as an adjunct to surgical repair (single or double row repair with sutures/suture anchors); 3. Patient is able and willing to complete the protocol required follow-up; 4. Patient is able and willing to sign the IRB approved informed consent; 5. 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: 1. Hypersensitivity to bovine-derived materials or poly(D,L-lactide) materials; 2. Patient with an irreparable or partially reparable rotator cuff tear; 3. Revision rotator cuff repair; 4. Off-label use of the study device; 5. Patient is known to be pregnant or nursing; 6. Patient is a prisoner; 7. Patient is a known alcohol or drug abuser; 8. Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that will not allow for proper informed consent or compliance with study requirements; 9. Patient is unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications; 10. Patient is unwilling or unable to give consent or to comply with the follow-up program; 11. Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
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Premier Ortho & Trauma Specialists
Pomona, California, 91767, United States
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UofL Health
Louisville, Kentucky, 40215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Brain signals and resilience: the hidden side of rotator cuff recovery
- MRI and biomarkers may predict rotator cuff repair success
- Can targeted nerve blocks ease shoulder surgery pain?
- Can treating the mind heal the shoulder? a surgery study investigates
- Can your beliefs about pain shape your shoulder disability?
- Could core strength hold the key to shoulder recovery?