Estradiol Supplementation and Rotator Cuff Repair — ESTRCR  

Menopause Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause 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, and function when given with rotator cuff repair.

Clinical Trial Description

Injuries to the rotator cuff are among the most common musculoskeletal complaints and are increasing in incidence. Multiple studies have demonstrated that rotator cuff repair (RCR) improves outcomes for rotator cuff tears. Over 500,000 RCRs are performed in the US annually. When both surgical and non-operative treatment are included, rotator cuff injuries cost the United States over $5 billion dollars annually. After RCR, tendon healing fails to occur in >20% of patients. Improving tendon healing is thus a critical barrier to success. The field has arrived at a consensus that improving tendon biology is the key to improving tendon healing. Our prior human and animal research demonstrates that estradiol deficiency contributes to rotator cuff injuries and estradiol supplementation improves RCR healing. With this study we propose to translate these promising and compelling preliminary findings into improved clinical care of patients with rotator cuff injuries. Estradiol deficiency can be treated with hormone therapy (HT), which is widely utilized, well-tolerated, inexpensive, and FDA approved. In this study, we will conduct a phase II study of the preliminary efficacy and feasibility of HT within the setting of RCR. We will conduct a randomized, placebo-controlled, double-blinded clinical trial. Post-menopausal women aged 40-80 will be included. Postoperatively, we will evaluate validated patient-reported outcomes and tendon healing utilizing magnetic resonance imaging. We hypothesize that outcomes and healing will be better in the HT group than the control group. Through this study we will also determine the feasibility of studying systemic HT in the setting of RCR. Although there is extensive clinical experience with HT in human women, there is none with RCR surgery. If preliminary efficacy is demonstrated, a future large, multi-center randomized clinical trial will be warranted. Thus, within our randomized controlled trial we will determine recruitment and retention rates, compliance with treatment, response to treatment of serum hormone levels, and adverse events. We hypothesize that compliance and response rates will be high while adverse events will be infrequent and equally common with estradiol patches and placebo patches. If our hypotheses are confirmed, then rationale will exist to translate this promising approach to improved healing and outcomes after RCR into a future, larger, well-powered, multi-centered randomized clinical trial with longer follow-up. Such a study could improve the treatment of people with rotator cuff injuries, thereby decreasing a source of significant disability. If our hypotheses are confirmed, it would shift the paradigm on the treatment of problems with tendons and their attachments to bone throughout the body. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06318403
• Study type: Interventional
• Source: University of Utah
• Contact: Peter Chalmers, MD
• Phone: 8015870063
• Email: chalmerspractice@hsc.utah.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2025
• Completion date: May 2028