Using a new implant to treat partial-thickness rotator cuff tears

Inclusion Criteria:

* The subject must provide written informed consent.
* Subject is \> eighteen (18) years of age (no upper limit).
* Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
* Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
* Subject willing and able to make all required study visits.
* Subject able to follow instructions and deemed capable of completing all study questionnaires.

Exclusion Criteria:

* 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 protocol 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 hypersensitivity to bovine-derived materials.
* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
* 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 with a full thickness rotator cuff tear.
* Subjects with a subscapularis tear requiring repair.
* 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).
* 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 pregnant or breast feeding.
* Subjects who are currently involved in any injury litigation relating to the index shoulder.
* Subjects with current workers compensation claim.
* Subjects who are enrolled, or plan to enroll, in another clinical trial 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 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.
* 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.