Bewertung der Sicherheit und Wirksamkeit der Anwendung von einer Schutzschicht aus Kollagen (das REGENETEN™ Bioinduktive Implantat ) bei der Rekonstruktion eines Sehnenrisses in der Schulter

Device: Arthroscopic rotator cuff repair with REGENETEN? Bioinductive Implant augmentation;Procedure: Arthroscopic rotator cuff repair;Device: Arthroscopic rotator cuff repair for revision surgery

Gender: All
Maximum age: N/A
Minimum age: 40 Years

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.