Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT06318403
Eligibility Criteria:
Inclusion Criteria
1. A plan for a primary rotator cuff repair
2. Female sex (assigned sex at birth)
3. \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
4. Post-menopausal, as defined by at least twelve months since last menses
5. Age 50-80
Exclusion Criteria
1. Active infection
2. Baseline serum estradiol \>20 pg/mL
3. Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3
4. Pre-operative systemic estradiol supplementation
5. Medically unfit for operative intervention
6. Revision surgery
7. Unwillingness to participate in the study, including post-operative imaging
8. Inability to read or comprehend written instructions
9. Prisoner
10. Concomitant patch augmentation or tendon-transfer
11. Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia
12. Liver disease as documented in the medical record
13. 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)
14. Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders
15. Isolated subscapularis tears
16. Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06318403
Study Brief:
Protocol Section:
NCT06318403