[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"massive-rotator-cuff-tear\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:massive-rotator-cuff-tear":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100621796","effects-of-biceps-transposition-without-tenotomy-for-augmentation-of-massive-rotator-cuff-repairs-100621796",false,"NCT07375277","Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs","Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs On Function, Quality Of Life, And Sleep: A Prospective Study","ROTATORCUFF","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and\u002For a tear with a greatest dimension greater than 5 cm\n* Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition\n* Persistence of symptoms despite at least 3 months of standard nonoperative treatment\n* Intact LHBT confirmed intraoperatively\n* Willingness and ability to attend scheduled follow-up visits (baseline, 3 months, and 12 months)\n* Provision of written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Tear patterns not requiring augmentation (e.g., preserved rotator cable patterns)\n* Neurologic conditions, inflammatory arthritis, active infection, or systemic conditions that may affect shoulder function or prevent protocol rehabilitation\n* Inability to provide informed consent\n* Expected nonadherence to follow-up or rehabilitation protocol","ALL","18 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective, single-arm interventional study will evaluate the effects of long head of the biceps tendon (LHBT) transposition without tenotomy as an augmentation technique for arthroscopic partial repair in adults with massive rotator cuff tears. Consecutive eligible patients undergoing arthroscopic partial rotator cuff repair plus tenotomy-sparing LHBT transposition augmentation at Balikesir City Hospital (Balikesir, Turkiye) will be enrolled and followed for 12 months. Patient-reported outcomes and clinical assessments will be collected preoperatively (baseline) and postoperatively at 3 and 12 months. The primary outcomes are shoulder function (ASES), rotator cuff-related quality of life (WORC converted to a 0-100 scale), and sleep disturbance (Insomnia Severity Index). Secondary outcomes include active shoulder range of motion and biceps-related clinical findings (Speed test, Yergason test, bicipital groove tenderness, and Popeye deformity). Postoperative MRI will not be obtained routinely and will be performed only if clinically indicated. The study aims to provide standardized prospective data on functional outcomes, quality of life, and sleep after this augmentation approach.",[27],"Massive Rotator Cuff Tear",[29,27,30],"Biceps Transposition","Arthroscopic Partial Repair","RECRUITING","2026-05-24",{"date":34,"type":35},"2026-05-28","ACTUAL",{"date":37,"type":35},"2026-03-26",{"date":39,"type":21},"2027-12-15",{"name":41,"class":42},"Ataturk University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100608968","voll-degradable-shoulder-spacer-fih-study-100608968","NCT07208448","Voll Degradable Shoulder Spacer FIH Study","A Multi-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears","Main Inclusion Criteria:\n\n* Full thickness MRCT.\n* Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits.\n\nMain Exclusion Criteria:\n\n* Documented evidence of a history of drug\u002Falcohol abuse within 1 year of enrollment.\n* Concurrent participation in any other investigational clinical study.","50 Years",{"count":53,"type":21},20,[24],"The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).",[27],"2026-03-05",{"date":59,"type":35},"2026-03-06",{"date":61,"type":35},"2025-12-09",{"date":63,"type":21},"2027-12-31",{"name":65,"class":66},"Voll Medical Technologies Ltd.","INDUSTRY",4,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":43},"100596931","lower-trapezius-tendon-transfer-vs-partial-cuff-repair-in-massive-rotator-cuff-tears-100596931","NCT07051889","Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears","TransfEr of the Lower Trapezius Tendon Versus Partial Cuff Repair Trial - TENET Trial","TENET","Inclusion Criteria:\n\n* Adult male and females over 18 years of age\n* MRI confirmed diagnosis of massive rotator cuff tears defined using the Schumaier 2020 definition of massive cuff tears which includes the following criteria:\n\n  * Retraction of the tendons to the glenoid rim, measured in either the coronal or axial plane\n  * Greater than or equal to 67% of the greater tuberosity exposed in the axial plane\n  * Diagnosed either with MRI or intra-operatively \\*\\* Note: patients may be screened for inclusion using ultrasound, and the Cofield or Gerber definitions of massive cuff tear defined as either 5cm or greater in maximum length or 2 more tendon involvement respectively, however their must meet the Schumaier et al 2020 definition for final inclusion.\n* Features of irreparability of their rotator cuff tendon tear including:\n\n  * Tendon retraction equal to or greater than 3cm16\n  * Remnant tendon length of supraspinatus \\\u003C15mm (as measured on coronal sequence of shoulder MRI)62\n  * Goutallier grade 3 or 4 fatty infiltration of the supraspinatus\n* An external rotation lag present on clinical exam. A positive external rotation lag will be considered as inability to perform external rotation with or against gravity.\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Patients with complete subscapularis tears\n* Patients with concomitant injuries of the affected shoulder\n* Previous surgery on the affected shoulder\n* Hamada grade 3 or above changes on plain films of the shoulder\n* Substantial shoulder comorbidity (e.g. Bankart lesion or osteoarthritis \\[defined as joint space narrowing or osteophytes present on radiographs and confirmed at the time of arthroscopy\\])\n* Substantial medical comorbidity that could impact the effectiveness of surgical intervention\n* Inability to speak English or French\n* Patients that will likely have difficulty with maintaining follow-up in the opinion of the evaluators (no fixed address, unwilling to be followed, incarcerated individuals, etc.)\n* Cases involving litigation or workplace insurance claims",{"count":77,"type":21},60,[24],"Very large tears of the shoulder tendons (the 'rotator cuff') that are not surgically repairable and in the absence of significant shoulder arthritis are common in older patients, and are associated with significant pain and functional limitations. Transfer of one particular tendon called the trapezius is becoming popular as a means of restoring function and improving pain in patients with massive rotator cuff tears. This tendon is appealing for transfer, as it has a similar line of pull to the infraspinatus (one of the rotator cuff tendons). There is currently no clear surgical consensus regarding the optimal treatment of patients with symptomatic massive irreparable rotator cuff tears that are appropriate candidates for joint salvage treatment, and no high level of evidence studies to guide clinical decision making have been published.\n\nA pilot study is required prior to the development of a full-scale trial to assess its feasibility and recruitment across clinical sites, to determine protocol adherence (errors in randomization), and patient retention over a 12-month period.\n\nThe main objective of this pilot trial is to assess a composite measure of feasibility including recruitment, protocol adherence, and patient retention at one-year. The secondary objectives, currently exploratory only, are to determine the clinical outcomes of lower trapezius tendon transfer versus arthroscopic rotator cuff partial repair and biceps tenodesis\u002Ftenotomy on clinical outcome measures, shoulder function, adverse events and reoperation rates at two-years.\n\nThis pilot study is a parallel-group multicentre randomized controlled trial with participating sites across Canada, and one site in the United States.",[27],"NOT_YET_RECRUITING","2025-07-02",{"date":84,"type":35},"2025-07-04",{"date":86,"type":21},"2025-08-01",{"date":88,"type":21},"2029-12-31",{"name":90,"class":42},"Ottawa Hospital Research Institute"]