[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540558":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":24,"responsibleParty":36,"collaborators":24,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":24,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":24,"overallStatus":64,"whyStopped":24,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":24},{"fullName":5,"class":6},"University of Utah","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Transdermal estradiol patches","EXPERIMENTAL","All patients will receive patches with identical labeling from our pharmacy, to be applied twice weekly. In the study group, these will contain 0.025 mg\u002Fday of estradiol. In the control group, these will be placebo. These will be applied twice weekly for three months beginning at the time of surgery and extending for three months after surgery.",[13,14],"Drug: Transdermal estrogen","Procedure: Rotator Cuff Repair Surgery",{"label":16,"type":17,"description":11,"interventionNames":18},"Placebo patches","PLACEBO_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Transdermal estrogen",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"PROCEDURE","Rotator Cuff Repair Surgery","The operative protocol will be standardized in all patients. Both the operative protocol and post-operative rehabilitation protocol will be per our standard of care, without alteration. An arthroscopic approach will be used. In all cases a double-row rotator cuff repair using triple-loaded anchor(s) on the medial row will be used. Post-operatively all patients will be placed in a sling for six weeks. Active range of motion exercises will begin at six weeks post-operatively and strengthening will be delayed until 12 weeks post-operatively. In all phases of care our peri-operative and post-operative protocol for study patients will be similar to our current clinical practice to ensure generalizability.",[16,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Peter Chalmers, MD","CONTACT","8015870063","chalmerspractice@hsc.utah.edu",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Peter Chalmers","Associate Professor of Orthopaedic Surgery, Principal Investigator","100540558","phase-2-estradiol-supplementation-and-rotator-cuff-repair-100540558",false,"NCT06318403","Estradiol Supplementation and Rotator Cuff Repair","Estradiol Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial","ESTRCR","Inclusion Criteria\n\n1. A plan for a primary rotator cuff repair\n2. Female sex (assigned sex at birth)\n3. \\>1 cm tear width, full thickness supraspinatus\u002Finfraspinatus tear\n4. Post-menopausal, as defined by at least twelve months since last menses\n5. Age 50-80\n\nExclusion Criteria\n\n1. Active infection\n2. Baseline serum estradiol \\>20 pg\u002FmL\n3. Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3\n4. Pre-operative systemic estradiol supplementation\n5. Medically unfit for operative intervention\n6. Revision surgery\n7. Unwillingness to participate in the study, including post-operative imaging\n8. Inability to read or comprehend written instructions\n9. Prisoner\n10. Concomitant patch augmentation or tendon-transfer\n11. Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia\n12. Liver disease as documented in the medical record\n13. Active venous thromboembolic disease, such as deep venous thrombosis, pulmonary embolism, a history of these conditions, or a known predisposition to these disorders (such as Protein C, protein S, or antithrombin deficiency)\n14. Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders\n15. Isolated subscapularis tears\n16. Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches","FEMALE","50 Years","80 Years",{"count":52,"type":53},58,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.",[59,60,61,62,63],"Rotator Cuff Tears","Rotator Cuff Injuries","Rotator Cuff Syndrome","Menopause Related Conditions","Menopause","NOT_YET_RECRUITING","2026-03-17",{"date":67,"type":68},"2026-03-19","ACTUAL",{"date":70,"type":53},"2028-03",{"date":72,"type":53},"2030-12",{"name":5,"class":6}]