Rotator Cuff Repair With Magnesium Pin
Status: Not yet recruiting

Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject requires Arthroscopic rotator cuff repair (ARCR) and amenable to repair. Subject is > 40 years of age (no upper limit); Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form; Subject is willing and able to participate in required follow-up visits and is able to complete study activities.  Exclusion Criteria:  Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications; Subjects with Samilson-Prieto osteoarthritis > 2; Subjects with current or prior infection of the ipsilateral shoulder; Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease; Subjects with prior shoulder surgery (not including rotator cuff repair (revision repair subject group only), biceps tenodesis/tenotomy, distal clavicle excision (DCE), ubacromial decompression); Subjects with an irreparable or partially reparable rotator cuff tear; Subjects with a subscapularis tear requiring repair; Subjects requiring a concomitant labral fixation procedure; Subjects requiring a concomitant os acromiale fixation procedure Subjects with glenohumeral joint instability (multiple dislocations/subluxations); Subjects with a subacromial or intra-articular injection within 3 months prior to surgery; 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; Pregnancy or possibility of pregnancy Patient's inability to understand written and spoken Chinese, Mandarin or English. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult