SuspendedNot Applicable

Tapestry Rotator Cuff Repair PMCF

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 range21 Years

SexALL

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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

✕. 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;

What they're measuring

Re-tear rate after arthroscopic rotator cuff repair

Timeframe: 6-month Post-operatively

Trial details

NCT IDNCT06287853

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12-30

View on ClinicalTrials.gov More Rotator Cuff Tears trials