Estradiol Supplementation and Rotator Cuff Repair

NCT06318403 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 177012
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Score

  The ASES score is a patient survey that creates a score on a 100 point scale incorporating questions regarding shoulder pain and shoulder function. This survey contains 11 questions and takes \~3 minutes to complete. The validity and reliability of this score has been previously validated.

  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.

Secondary Outcomes (5)

• Simple Shoulder Test (SST) Score

  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.

• Visual Analogue Score (VAS) for pain

  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.

• Magnetic Resonance Imaging (MRI)

  Within 3 months pre-operatively and at 6 months (±4 weeks) post-operatively.

• Strength Assessment

  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.

• Range of motion

  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.

Other Outcomes (3)

• Serum Hormone Measurement

  To be collected within 3 months pre-operatively, at 6 weeks (±1 week) after starting medication, and at 12 weeks (±2 weeks) after starting medication.

• Patch Count

  6 weeks (±2 weeks) post-operatively, 12 weeks (±2 week) post-operatively.

• Averse Event Assessment

  To be collected at every patient visit, including 6 weeks (±2 weeks) after surgery, 12 weeks (±2 weeks) after surgery, and 6 months (±4 weeks) after surgery.

Study Arms (2)

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/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.

Drug: Transdermal estrogen; Procedure: Rotator Cuff Repair Surgery

Placebo patches

PLACEBO COMPARATOR

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

Interventions

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.

Placebo patches; Transdermal estradiol patches

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.

Transdermal estradiol patches

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A plan for a primary rotator cuff repair
• Female sex (assigned sex at birth)
• \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
• Post-menopausal, as defined by at least twelve months since last menses
• Age 50-80

You may not qualify if:

• Active infection
• Baseline serum estradiol \>20 pg/mL
• Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3
• Pre-operative systemic estradiol supplementation
• Medically unfit for operative intervention
• Revision surgery
• Unwillingness to participate in the study, including post-operative imaging
• Inability to read or comprehend written instructions
• Prisoner
• Concomitant patch augmentation or tendon-transfer
• Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia
• Liver disease as documented in the medical record
• 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)
• Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders
• Isolated subscapularis tears

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Peter Chalmers, MD

CONTACT

8015870063; chalmerspractice@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery, Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start (Estimated): March 1, 2028
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share