[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489969":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":66,"studyPopulation":57,"armGroups":67,"interventions":83,"overallOfficials":92,"centralContacts":96,"locations":101,"responsibleParty":165,"collaborators":57,"id":168,"slug":57,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":57,"eligibilityCriteria":173,"healthyVolunteers":169,"sex":174,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":57,"studyType":180,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":104,"whyStopped":57,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"La Tour Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"ASES score","American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).","At 24 post-operative months",[14,17,20,23,26,29,32,36,39,43,45,47,49,51,53,55],{"measure":15,"description":16,"timeFrame":12},"VAS pain","Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)",{"measure":18,"description":19,"timeFrame":12},"SSV","Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).",{"measure":21,"description":22,"timeFrame":12},"LHB score","Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).",{"measure":24,"description":25,"timeFrame":12},"AFF","Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator",{"measure":27,"description":28,"timeFrame":12},"ER at side","External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator",{"measure":30,"description":31,"timeFrame":12},"IR","Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator",{"measure":33,"description":34,"timeFrame":35},"Complications","Any type of post-operative complication","Within 2 postoperative years",{"measure":37,"description":38,"timeFrame":12},"Patient satisfaction","Yes or no",{"measure":40,"description":41,"timeFrame":42},"Location of the defect (at the foot print | medial cuff failure)","Radiographic outcome evaluated using an ultrasound examination.","At 6 post-operative month",{"measure":44,"description":41,"timeFrame":42},"Status of the biceps tendon (intact | in continuity | defect)",{"measure":46,"description":41,"timeFrame":42},"Signs of anchor displacement and location (lateral | medial row).",{"measure":48,"description":41,"timeFrame":42},"Tendon thickness",{"measure":50,"description":41,"timeFrame":42},"Number of patients with bursitis",{"measure":52,"description":41,"timeFrame":42},"Number of patients with healing of the Supraspinatus tear according to Sugaya classification",{"measure":54,"description":41,"timeFrame":42},"Number of patients with liquid in the bicipital sheath",{"measure":56,"description":41,"timeFrame":42},"Number of patients with hypervascularization of the sheath",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":63,"maskingDescription":57,"whoMasked":64},"SINGLE",[65],"OUTCOMES_ASSESSOR","The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.",[68,72,78],{"label":69,"type":70,"description":71,"interventionNames":57},"Leaving LHB Intact","NO_INTERVENTION","The long head of the biceps (LHB) will be left intact.",{"label":73,"type":74,"description":75,"interventionNames":76},"LHB tenotomy","EXPERIMENTAL","The long head of the biceps (LHB) will be cut at its origin.",[77],"Procedure: LHB Tenotomy",{"label":79,"type":74,"description":80,"interventionNames":81},"LHB Tenodesis","The long head of the biceps (LHB) will be cut at its origin and reattached.",[82],"Procedure: LHB Tenodesis",[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":57},"PROCEDURE","LHB Tenotomy","Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors",[73],{"type":85,"name":79,"description":90,"armGroupLabels":91,"otherNames":57},"\"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.",[79],[93],{"name":94,"affiliation":5,"role":95},"Alexandre Lädermann, MD","PRINCIPAL_INVESTIGATOR",[97],{"name":94,"role":98,"phone":99,"phoneExt":57,"email":100},"CONTACT","+41 22 71 975 55","alexandre.laedermann@gmail.com",[102,120,134,150],{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Sports Medicine and Shoulder Surgery, University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":111,"coordinates":112},"Point",[113,114],-83.74088,42.27756,{"lat":114,"lon":113},[117],{"name":118,"role":98,"phone":57,"phoneExt":57,"email":119},"Asheesh Bedi, MD","asheesh.bedi@gmail.com",{"facility":121,"status":104,"city":122,"state":123,"zip":124,"country":108,"countryCode":109,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Oregon Health & Science University","Portland","Oregon","97239",{"type":111,"coordinates":126},[127,128],-122.67621,45.52345,{"lat":128,"lon":127},[131],{"name":132,"role":98,"phone":57,"phoneExt":57,"email":133},"Patrick Denard, MD","pjdenard@gmail.com",{"facility":135,"status":104,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Group 23 Sports Medicine","Calgary","Alberta","T3B 6B7","Canada","CA",{"type":111,"coordinates":142},[143,144],-114.08529,51.05011,{"lat":144,"lon":143},[147],{"name":148,"role":98,"phone":57,"phoneExt":57,"email":149},"Ian K Lo, MD","ikylo@ucalgary.ca",{"facility":151,"status":104,"city":152,"state":153,"zip":154,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"la Tour hospital","Meyrin","Canton of Geneva","1217","Switzerland","CH",{"type":111,"coordinates":158},[159,160],6.08025,46.23424,{"lat":160,"lon":159},[163],{"name":94,"role":98,"phone":164,"phoneExt":57,"email":100},"+41 22 719 75 55",{"type":95,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Dr. Alexandre Lädermann","Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology","100489969",false,"NCT05660031","Treatment of the Biceps With Concomitant Supraspinatus Tears","Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial","Inclusion Criteria:\n\n* Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.\n* Full thickness tear of the supraspinatus tendon\n* Intact subscapularis tendon\n* Primary rotator cuff repair\n* Age 50-80\n\nExclusion Criteria:\n\n* Previous full thickness biceps tear\n* Infection and neuropathic joints\n* Known or suspected non-compliance, drug or alcohol abuse\n* Patients incapable of judgement or under tutelage\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons\n* Patient declines to participate in study","ALL","50 Years","80 Years",{"count":178,"type":179},180,"ESTIMATED","INTERVENTIONAL",[182],"NA","The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.",[185],"Supraspinatus Tear",[187,188,189,190,191],"Long head of the biceps","Supraspinatus tear","tenotomy","tenodesis","rotator cuff repair","2025-04-23",{"date":194,"type":195},"2025-04-25","ACTUAL",{"date":197,"type":195},"2021-06-01",{"date":199,"type":179},"2026-06-01",{"name":5,"class":6},4]