Tapestry Rotator Cuff Repair PMCF
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.
- EligibilityCriteria: 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:  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); 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; Patient is unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications; Patient is unwilling or unable to give consent or to comply with the follow-up program; Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 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. - SamplingMethod: Non-Probability Sample