Comparing Isolated Bioinductive Repair with Completion and Repair for rotator cuff injuries

Exclusion

• −Subjects with known hypersensitivity to bovine-derived materials.
• −Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
• −Subjects where the prescribed Physical Therapy guidelines stated in the protocolProtocolThe detailed plan a study must follow.Read more → are not suitable for their rehabilitation.
• −Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
• −Subjects with current or prior infection of the ipsilateral shoulder.
• −Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), armArmOne of the groups in a study, each receiving something different.Read more →(s)).
• −Subjects with a full thickness rotator cuff tear.
• −Subjects with a subscapularis tear requiring repair.
• −Subjects requiring a concomitant os acromiale fixation procedure.
• −Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
• −Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair 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.
• −Subjects with neurologic conditions effecting either upper extremity.
• −Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
• −Subjects who are currently involved in any injury litigation relating to the index shoulder.
• −Subjects with current workers compensation claim.
• −Subjects who are enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →, or plan to enroll, in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → during this study that would affect the outcomes of this study.
• −Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
• −Subject who, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
• −Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
• −Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
• −Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
• −Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
• −Subjects who are pregnant or breast feeding.
• −Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
• −Subjects with a planned surgery on the contra-lateral shoulder within the study period.
• −Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
• −Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).