Estradiol Supplementation and Rotator Cuff Repair

Launched by UNIVERSITY OF UTAH · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether using estradiol patches can help improve recovery for post-menopausal women who have had surgery to repair a rotator cuff tear in the shoulder. Rotator cuff tears can cause significant pain and often don't heal well after surgery. Researchers believe that low levels of estradiol, a hormone that decreases after menopause, might be linked to poorer healing outcomes. In this trial, women aged 50 to 80 who are undergoing primary rotator cuff repair and have specific types of tears will be randomly assigned to receive either estradiol patches or placebo patches (which contain no medication) to see if the patches can enhance shoulder pain relief, strength, and overall function after surgery.

To participate in this study, women must be post-menopausal (meaning they have not had a menstrual period for at least a year) and have a full-thickness tear in their rotator cuff that is wider than 1 cm. However, some individuals may not be eligible if they have certain health issues, like active infections or specific medical histories. Participants will be asked to follow up with post-operative imaging to assess their recovery. This trial is not yet recruiting, but it aims to provide insights that could help improve shoulder surgery outcomes for women in the future.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • 1. A plan for a primary rotator cuff repair
• • 2. Female sex (assigned sex at birth)
• • 3. \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
• • 4. Post-menopausal, as defined by at least twelve months since last menses
• • 5. Age 50-80
• • Exclusion Criteria
• • 1. Active infection
• • 2. Baseline serum estradiol \>20 pg/mL
• • 3. Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3
• • 4. Pre-operative systemic estradiol supplementation
• • 5. Medically unfit for operative intervention
• • 6. Revision surgery
• • 7. Unwillingness to participate in the study, including post-operative imaging
• • 8. Inability to read or comprehend written instructions
• • 9. Prisoner
• • 10. Concomitant patch augmentation or tendon-transfer
• • 11. Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia
• • 12. Liver disease as documented in the medical record
• • 13. 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)
• • 14. Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders
• • 15. Isolated subscapularis tears
• • 16. Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches