Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-12
Brief Title:
Estradiol Supplementation and Rotator Cuff Repair
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Estradiol Supplementation and Rotator Cuff Repair A Preliminary Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTRCR
Brief 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
Detailed 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 500000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None