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.
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
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
Parallel
Transdermal estrogen
DrugAll 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.
Rotator Cuff Repair Surgery
Procedure/SurgeryThe 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.
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.
Simple Shoulder Test (SST) Score
The SST score is a patient survey that creates a score on a 12-point scale incorporating questions regarding shoulder function. This survey contains 12 questions and takes \~3 minutes to complete. The validity and reliability of this score has been previously validated.
Visual Analogue Score (VAS) for pain
The VAS pain score is a patient survey that creates a score on a 10 point scale incorporating a single question regarding shoulder pain. This survey takes \<1 minute to complete.
Magnetic Resonance Imaging (MRI)
MRI scans will be assessed by observers blinded to the patient's allocation. On the pre-operative MRI, pre-operative tear width, pre-operative tear retraction, cuff muscle atrophy using the Goutallier10 classification will be measured. For each patient, the post-operative MRI will be classified using the Sugaya classification, which multiple authors have demonstrated to have excellent inter-observer reliability. Sugaya grades 1, 2, and 3 will be considered "healed" and Sugaya grades 4 and 4 will be considered "re-torn". In cases of re-tear, tear width and retraction will be measured. In addition, on both pre-operative and post-operative scans rotator cuff muscle volumes will be measured, for which we have previously demonstrated to have excellent inter-observer reliability and accuracy. All post-operative MRI scans will be 3.0 tesla non-arthrogram studies in which T2 imaging will be performed in the sagittal, coronal, and axial planes.
Strength Assessment
Rotator cuff strength, as measured with a handheld digital dynamometer (Lafayette instruments, Lafayette, IN), will be measured. Abduction strength will be measured at 30 degrees of flexion, 30 degrees of abduction, neutral rotation, and full elbow extension. External rotation strength will be measured with the arm in adduction, neutral rotation, and 90 degrees of elbow flexion. These measures will be performed by research coordinators trained to perform these assessments. We have previously demonstrated these measurements to have excellent inter-observer reliability, with abduction strength having an intra-class correlation coefficient (ICC) of 0.993 and external rotation strength having an ICC of 0.986.
Serum Hormone Measurement
Nonadherence could result in cross-over, biasing towards the null hypothesis. We will assess compliance with serum laboratory values. Blood will be drawn and the following serum estradiol values will be collected. These values will be interpreted by co-investigator Dr. Corrine Welt, a board-certified endocrinologist with extensive experience with reproductive urology. To preserve participant blinding, the results of hormonal testing will not be available through the patient electronic portal unless it is deemed necessary for patient care by Dr. Welt. In addition, to preserve their blinding, the treating surgeons and the clinical research coordinators performing the post-operative assessments will not have access to the laboratory values. Dr. Welt will not perform any other patient evaluations, and thus cannot influence the results.
Patch Count
Subjects will be asked how many patches they have used to determine patient compliance. Deviations from protocol will be recorded.
Averse Event Assessment
At each visit patients will be queried regarding adverse events. Patients will asked about the following specific adverse events side effects: dyspepsia/gastritis, hypertension, flu-like symptoms, back-pain, headache, anxiety, insomnia, depression, breast tenderness, vaginal bleeding, hot flashes, venous insufficiency, vertigo, edema, deep venous thrombosis, application site reactions, abdominal pain, weight gain, emotional lability, bleeding, infection, complications from anesthesia, the need for further surgery. In addition, any post-operative injections will be recorded.
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