Clinical trial NCT06353893: MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears
Official title: Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Rotator Cuff Tears
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Anika Therapeutics, Inc.
First posted: 2024-04-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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:

* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
* Subject can read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

* Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
* If patient is pregnant;
* Subject conditions which may hinder the healing process;
* Subject is a prisoner or member of another vulnerable population.

Primary outcomes:
measure: MRI Assessment of Adverse Events and Structural Integrity
timeFrame: 3 and 6 months after index procedure
Secondary outcomes:
measure: Effectiveness Evaluation with PROMIS outcome tool
timeFrame: 3 months after index procedure
measure: Effectiveness Evaluation with PROMIS tool
timeFrame: 6 months after index procedure
measure: Effectiveness Evaluation with SANE score
timeFrame: 3 months after index procedure
measure: Effectiveness Evaluation with SANE score
timeFrame: 6 months after index procedure
measure: Effectiveness Evaluation with ASES rating scale
timeFrame: 3 months after index procedure
measure: Effectiveness Evaluation with ASES rating scale
timeFrame: 6 months after index procedure
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
Study officials:
References: