An observational study in Rotator Cuff Tears, sponsored by Foundation for Orthopaedic Research and Education. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Foundation for Orthopaedic Research and Education · Observational
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:
Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
The aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly FDA-cleared Integrity graft for various types of rotator cuff repairs. This study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. The primary objective is to document the safety profile of the Integrity graft by monitoring device-related adverse events throughout the study duration. Additionally, the study aims to assess the post-market effectiveness of the Integrity implant using patient-reported outcome measures and establish normal or standard findings on MRI to aid surgeons in clinical decision-making.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 20 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Foundation for Orthopaedic Research and Education is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from patients with a history of rotator cuff repair surgery one to 83 days (about 2 and a half months) before the screening.
Exclusion Criteria:
The implant is a porous, flexible construct knitted using HYAFF® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika's proven and proprietary esterified HA technology that resorbs over time as tissue remodels. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears.
MRI Assessment of Adverse Events and Structural Integrity
The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.
Time frame: 3 and 6 months after index procedure
Effectiveness Evaluation with PROMIS outcome tool
The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life in a questionnaire which is scored)
Time frame: 3 months after index procedure
Effectiveness Evaluation with PROMIS tool
The secondary endpoints of the study include evaluating PROMIS scores (assessing various aspects of quality of life)
Time frame: 6 months after index procedure
Effectiveness Evaluation with SANE score
The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)
Time frame: 3 months after index procedure
Effectiveness Evaluation with SANE score
The secondary endpoints of the study include evaluating SANE scores: Single assessment numeric rating scale of 0-10 with 0 being NO pain and 10 being worst or severe pain (patients' perceived improvement)
Time frame: 6 months after index procedure
Effectiveness Evaluation with ASES rating scale
The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain) ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.
Time frame: 3 months after index procedure
Effectiveness Evaluation with ASES rating scale
The secondary endpoints of the study include evaluating ASES rating scale (for shoulder function and pain)ASES is a mixed-outcome reporting tool, meaning it consists of a physician-rated and patient-rated questionnaire. The patient-rated questionnaire focuses on joint pain, instability and activities of daily living.
Time frame: 6 months after index procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Foundation for Orthopaedic Research and Education