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NOT YET RECRUITING
NCT06318403
PHASE2

Estradiol Supplementation and Rotator Cuff Repair

Sponsor: University of Utah

View on ClinicalTrials.gov

Summary

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.

Official title: Estradiol Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

Key Details

Gender

FEMALE

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2028-03

Completion Date

2030-12

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Transdermal estrogen

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/day 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.

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.