use of the regeneten™ bioinductive implant system in high grade partial-thickness tears

Conditions: Rotator Cuff Injuries

Summary: the purpose of the study is to assess whether the regeneten™ bioinductive implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'completion and repair' for surgically treating partial-thickness rotator cuff tears.

the primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either isolated bioinductive repair (ibr) or completion and repair (car).

Eligibility criteria:
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.

Keywords: rotator cuff tear high grade partial thickness tears regeneten bioinductive implant system