Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
University of Utah
58 participants
Mar 9, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- A plan for a primary rotator cuff repair
- Male sex
- \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
Exclusion Criteria12
- Active infection
- Pre-operative testosterone supplementation
- Known diagnosis of secondary testicular failure or testosterone deficiency
- Medically unfit for operative intervention
- Revision surgery
- Unwillingness to participate in the study, including post-operative imaging
- Inability to read or comprehend written instructions
- Prisoner
- Concomitant patch augmentation or tendon-transfer
- Untreated prostate cancer
- Liver disease
- Pituitary or hypothalamic dysfunction
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Interventions
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.
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.
Locations(1)
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NCT04944836