[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06848023":3,"trial-entities:NCT06848023":115,"trial-summary:NCT06848023":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":53,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":80,"locations":83,"central_contacts":92,"overall_officials":93,"references":97,"see_also_links":114},"NCT06848023","25-010480-XP","Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+","Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears","ENROLLING_BY_INVITATION","2026-12","2025-07","2025-07-28","2025-06-10","Campbell Clinic","OTHER",false,"To compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.","A retrospective record review will be completed to identify eligible subjects who had either a reverse total shoulder arthroplasty or rotator cuff repair to treat their three tendon tear. Medical record abstraction of standard of care will be completed among the reverse total shoulder arthroplasty cohort. Rotator cuff repair subjects will be contacted with a study invitation and scheduled for a single study visit to collect three patient reported outcomes, assess range of motion and complete a ten-minute magnetic resonance imaging exam following signed consent.",[19,20],"Shoulder Injuries","Shoulder Pain",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},74,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Reverse Total Shoulder Arthroplasty","standard of care treatment reverse total shoulder arthroplasty delivered",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Rotator Cuff Repair","standard of care treatment rotator cuff repair delivered",[35],[39,43,45,48,49,52],{"measure":40,"description":41,"timeFrame":42},"American Shoulder Elbow Surgeons","numeric scale to quantify shoulder function from zero (worst) to one hundred (best)","90 days before surgery to day of surgery",{"measure":40,"description":41,"timeFrame":44},"one year after surgery",{"measure":46,"description":47,"timeFrame":42},"Visual Analog Scale","numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)",{"measure":46,"description":47,"timeFrame":44},{"measure":50,"description":51,"timeFrame":42},"Single Assessment Numeric Evaluation","Satisfaction with Shoulder",{"measure":50,"description":51,"timeFrame":44},[54,57,60,64],{"measure":55,"description":56,"timeFrame":44},"Revision rate","occurrence of repeat surgery",{"measure":58,"description":59,"timeFrame":44},"Sugaya","Measure of tendon quality from one (intact) to five (completely torn)",{"measure":61,"description":62,"timeFrame":63},"Range of motion","shoulder movement measurement","90 day to surgery",{"measure":61,"description":62,"timeFrame":44},"ALL","60 Years","95 Years",{"inclusion":69,"exclusion":73,"raw_text":79},[70,71,72],"60 years of age or more at time of surgery","One year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis)","Surgery completed by Dr. Tyler Brolin or Dr. Thomas Throckmorton",[74,75,76,77,78],"Less than 60 years of age at time of surgery","Less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair","Procedure completed by another provider than Dr. Brolin or Dr. Throckmorton","Worker's compensation","Fewer than three tendon tear","Inclusion Criteria:\n\n* 60 years of age or more at time of surgery\n* One year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis)\n* Surgery completed by Dr. Tyler Brolin or Dr. Thomas Throckmorton\n\nExclusion Criteria:\n\n* Less than 60 years of age at time of surgery\n* Less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair\n* Procedure completed by another provider than Dr. Brolin or Dr. Throckmorton\n* Worker's compensation\n* Fewer than three tendon tear",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Germantown","Tennessee","38138","United States",{"lat":90,"lon":91},35.08676,-89.81009,[],[94],{"name":95,"affiliation":13,"role":96},"Tyler J Brolin, MD","PRINCIPAL_INVESTIGATOR",[98,102,105,108,111],{"pmid":99,"type":100,"citation":101},"30650169","RESULT","Allert JW, Sellers TR, Simon P, Christmas KN, Patel S, Frankle MA. Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty. Am J Orthop (Belle Mead NJ). 2018 Dec;47(12). doi: 10.12788\u002Fajo.2018.0109.",{"pmid":103,"type":100,"citation":104},"25155203","Jacquot A, Dezaly C, Goetzmann T, Roche O, Sirveaux F, Mole D; French Society for Shoulder, Elbow (SOFEC). Is rotator cuff repair appropriate in patients older than 60 years of age? prospective, randomised trial in 103 patients with a mean four-year follow-up. Orthop Traumatol Surg Res. 2014 Oct;100(6 Suppl):S333-8. doi: 10.1016\u002Fj.otsr.2014.04.004. Epub 2014 Aug 23.",{"pmid":106,"type":100,"citation":107},"23365029","Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302\u002F0301-620X.95B2.30246.",{"pmid":109,"type":100,"citation":110},"38618461","Gowda CS, Mirza K, Galagali DA. Rotator Cuff Tears: Correlation Between Clinical Examination, Magnetic Resonance Imaging and Arthroscopy. Cureus. 2024 Mar 12;16(3):e56065. doi: 10.7759\u002Fcureus.56065. eCollection 2024 Mar.",{"pmid":112,"type":100,"citation":113},"38218405","Adam MF, Ladermann A, Denard PJ, Lacerda F, Collin P. Preoperative diagnosis and rotator cuff status impact functional internal rotation following reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2024 Jul;33(7):1570-1576. doi: 10.1016\u002Fj.jse.2023.11.020. Epub 2024 Jan 11.",[],{"nct_id":4,"conditions":116,"biomarkers":118},[117,20],"Injury of shoulder region",[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]