Estradiol Supplementation and Rotator Cuff Repair

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50-80
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transdermal estrogen
  • Rotator Cuff Repair Surgery

Treatment groups

58 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators