Estradiol Supplementation and Rotator Cuff Repair

Sponsor
University of Utah
Study ID
NCT06318403
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Menopause
  • Menopause Related Conditions
  • Rotator Cuff Injuries
  • Rotator Cuff Syndrome
  • Rotator Cuff Tears

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transdermal estrogen — DRUG
    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.
  • Rotator Cuff Repair Surgery — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Mar 19, 2024
Start date
Mar 31, 2028
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transdermal estradiol patches
    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.
  • Placebo Comparator: Placebo patches
    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.

Primary Outcome Measure

American Shoulder and Elbow Surgeons (ASES) Score [ Time Frame: To be collected within 3 months pre-operatively and at 6 weeks (±2 weeks), 12 weeks (±2 weeks), and 6 months (±4 weeks) post-operatively. ]

Central Contacts

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