REGENETENâ„¢ Bioinductive Implant System in Full-thickness Tears (NCT04450342) | Clinical Trial Compass
TerminatedNot Applicable
REGENETENâ„¢ Bioinductive Implant System in Full-thickness Tears
Stopped: Sponsor decision not related to safety.
United States119 participantsStarted 2020-12-07
Plain-language summary
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed;
✓. Subject is \> 40 years of age (no upper limit);
✓. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
✓. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Exclusion criteria
✕. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
✕. Subjects with Samilson-Prieto osteoarthritis \> 2;
✕. Subjects with current or prior infection of the ipsilateral shoulder;
✕. Subjects with known hypersensitivity to bovine-derived materials;
✕. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
✕. Subjects with prior shoulder surgery (not including rotator cuff repair \[revision repair subject group only\], biceps tenodesis/tenotomy, distal clavicle excision \[DCE\], subacromial decompression);