protocolSection identificationModule nctId: NCT06292754, orgStudyIdInfo id: 2023.211, briefTitle: Rotator Cuff Repair With Magnesium Pin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Arthroscopic Rotator Cuff Repair, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: magnesium pin in additional to the suture anchor, interventions name: routine suture anchor, outcomesModule primaryOutcomes measure: Imaging Examinations, primaryOutcomes measure: Cofield classification, primaryOutcomes measure: Sugaya Score, primaryOutcomes measure: Goutallier Classification, secondaryOutcomes measure: Height measurement, secondaryOutcomes measure: Weight measurement, secondaryOutcomes measure: BMI measurement, secondaryOutcomes measure: Shoulder flexibility (range of motion), secondaryOutcomes measure: Shoulder muscle strength, secondaryOutcomes measure: Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index, secondaryOutcomes measure: Constant-Murley Score, secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: C-reactive protein measurement, secondaryOutcomes measure: Calcium (Ca) measurement, secondaryOutcomes measure: Magnesium (Mg) measurement, secondaryOutcomes measure: Phosphorous (P) measurement, secondaryOutcomes measure: Creatinine (Cr) measurement, secondaryOutcomes measure: Urea measurement, secondaryOutcomes measure: Alanine transaminase (ALT) measurement, secondaryOutcomes measure: Aspartate aminotransferase (AST) measurement, secondaryOutcomes measure: Total protein (TP) measurement, secondaryOutcomes measure: Albumin (ALB) measurement, secondaryOutcomes measure: Globulin (GLB) measurement, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False