Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40-80
SponsorUniversity of Utah
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
A plan for a primary rotator cuff repair
Male sex
>1 cm tear width, full thickness supraspinatus/infraspinatus tear
Disqualifiers
Active infection
Pre-operative testosterone supplementation
Known diagnosis of secondary testicular failure or testosterone deficiency
Medically unfit for operative intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Clomiphene Citrate
DrugAll 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.
Rotator Cuff Repair
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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: ClomipheneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Magnetic Resonance Imaging (MRI) tendon healing Post-op
MRI scans will be assessed by observers blinded to the patient's allocation. For each patient, the post-operative MRI will be categorized as either "healed" or "non-healed". On post-operative MRI only those patients without tendon defects will be considered to be healed. This will be the primary outcome of the study. The investigators have previously demonstrated this measurement to be reliable.
Time frame
To be collected at 6 months (±4 weeks) post-operatively.Secondary outcomes
1
American Shoulder and Elbow Surgeons (ASES) Score Pre-op
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. Higher scores indicate a better outcome.
Time frame
To be collected within six months pre-operatively.2
American Shoulder and Elbow Surgeons (ASES) Score 6 weeks
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. Higher scores indicate a better outcome.
Time frame
To be collected at six weeks (±2 weeks) post-operatively.3
American Shoulder and Elbow Surgeons (ASES) Score 12 weeks
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. Higher scores indicate a better outcome.
Time frame
To be collected at 12 weeks (±2 weeks) post-operatively.4
American Shoulder and Elbow Surgeons (ASES) Score 6 months
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. Higher scores indicate a better outcome.
Time frame
To be collected at 6 months (±4 weeks) post-operatively.Other outcomes
1
Serum Hormone Measurement Surgery
Blood will be drawn and the following serum laboratory values will be collected: testosterone, bio-available testosterone, estradiol, all of which are reported in ng/dL.
Time frame
To be collected at the time of surgery.2
Luteinizing Hormone Measurement Surgery
Blood will be drawn and serum luteinizing hormone values will be collected. These are reported in IU/L.
Time frame
To be collected at the time of surgery.3
Serum Hormone Measurement 12 weeks
Blood will be drawn and the following serum laboratory values will be collected: testosterone, bio-available testosterone, and estradiol, all of which are reported in ng/dL.
Time frame
To be collected at 12 weeks (±2 weeks) post-operatively.4
Luteinizing Hormone Measurement 12 weeks
Blood will be drawn and serum luteinizing hormone values will be collected. These are reported in IU/L.
Time frame
To be collected at 12 weeks (±2 weeks) post-operatively.Sponsors and contacts
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Source ClinicalTrials.gov