Estradiol Supplementation and Rotator Cuff Repair

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 31, 2026

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Rotator Cuff TearsRotator Cuff InjuriesRotator Cuff SyndromeMenopause Related ConditionsMenopause
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.

All Listed Sponsors
lead

University of Utah

OTHER