Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
University of Utah
Summary
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.
Description
The rotator cuff is a system of tendons in the shoulder that stabilize the ball within the socket. These tendons frequently tear with age, which causes pain, weakness, and dysfunction in the shoulder. While these tears can be surgically repaired, they do not always heal. Our data suggest that deficiency of testosterone and estrogen can contribute to both tearing of the rotator cuff and failure of healing after rotator cuff repair. Testosterone can be converted into estrogen in the body through the aromatase enzyme, which is in both tendons and bones, as well as other tissues. Both testosterone…
Eligibility
- Age range
- 40–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria 1. A plan for a primary rotator cuff repair 2. Male sex 3. \>1 cm tear width, full thickness supraspinatus/infraspinatus tear Exclusion Criteria 1. Active infection 2. Pre-operative testosterone supplementation 3. Known diagnosis of secondary testicular failure or testosterone deficiency 4. Medically unfit for operative intervention 5. Revision surgery 6. Unwillingness to participate in the study, including post-operative imaging 7. Inability to read or comprehend written instructions 8. Prisoner 9. Concomitant patch augmentation or tendon-transfer 10. Untreated prostate…
Interventions
- DrugClomiphene Citrate
All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. In the control group, these will be placebo. These will be taken every other day for seven months beginning four weeks prior to surgery and extending for six months after surgery. After enrollment patients will be randomized. Patient will be assigned to the 2 groups using a permuted block randomization scheme with blocks of size 2, 4, and 6. Prior to initiation of the study opaque sealed envelopes will be prepared and thoroughly shuffled and then used sequentially during the study. These randomization assignments will be available to the pharmacy in a web-based format or by cards in sealed envelopes. A nonparticipant in the study (the pharmacy at our institution) will administer this process.
- ProcedureRotator Cuff Repair
The 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.
Location
- University of UtahSalt Lake City, Utah