REGENETEN™ Bioinductive Implant System in Full-thickness Tears

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone

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.

This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.

Inclusion Criteria:

1. Subject requires Arthroscopic rotator cuff repair (ARCR);
2. 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;
3. Subject is > 40 years of age (no upper limit);
4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.

Exclusion Criteria:

1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
2. Subjects with Samilson-Prieto osteoarthritis > 2;
3. Subjects with current or prior infection of the ipsilateral shoulder;
4. Subjects with known hypersensitivity to bovine-derived materials;
5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);
7. Subjects with an irreparable or partially reparable rotator cuff tear;
8. Subjects with a subscapularis tear requiring repair;
9. Subjects requiring a concomitant labral fixation procedure;
10. Subjects requiring a concomitant os acromiale fixation procedure;
11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
14. Subjects who are pregnant or breast feeding;
15. Subjects who are currently involved in any injury litigation or workers compensation claims;
16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;
17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation
18. Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse;
19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.