Clinical trial NCT04944836: Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
Official title: Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rotator Cuff Tears
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 58
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 and estrogen can improve bone quality. While testosterone is frequently prescribed for testosterone deficiency, when it is given your body no longer has the drive to make testosterone. So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more. As a result, testosterone is not usually given temporarily. For temporary treatment clomiphene avoids this issue. Clomiphene works at the feedback mechanisms within the body to trick the body into thinking testosterone and estrogen levels are low and thus to motivate it to make more testosterone and estrogen. However, clomiphene can only be given continuously to men, because women's estrogen levels regularly cycle up and down on a monthly basis and clomiphene interferes with this cycle. The purpose of this study is to determine whether clomiphene treatment decreases pain and improves function, increases tendon healing, and improves bone quality with rotator cuff repair in men. We hypothesize that clomiphene treatment will decrease pain and improve function, improve tendon healing, and improve bone quality with rotator cuff repair in men. This is a placebo-controlled study, so a control group of patients will received placebo pills, i.e. "sugar pills", instead of clomiphene. This is a randomized study, so patients enrolled in the study will be randomly assigned to the clomiphene group or the placebo group. This is a blinded study, so both the patients enrolled in the will not know whether they are in the clomiphene or the control group. This is a double-blinded study, so the doctors performing the surgeries and the study will not know whether each specific patient is in the clomiphene or the control group. Study participants will first start the clomiphene treatment one month before surgery and will continue the treatment for six months after surgery. Both before surgery and six months after surgery, study participants will fill out study questionnaires about shoulder pain and function. Both before surgery and six months after surgery, study participants will undergo an magnetic resonance imaging study to examine the rotator cuff tendons as well as the bone quality within the shoulder. The magnetic resonance imaging study after surgery is provided free to study participants. Study participants will be compensated for completing the study. These results are important because may lead to a better understanding of the problem, more effective treatment, and improved clinical outcomes for future patients.

Eligibility criteria: 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 cancer
11. Liver disease
12. Pituitary or hypothalamic dysfunction

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) tendon healing Post-op
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Score Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: American Shoulder and Elbow Surgeons (ASES) Score 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: American Shoulder and Elbow Surgeons (ASES) Score 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: American Shoulder and Elbow Surgeons (ASES) Score 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Simple Shoulder Test (SST) Score Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: Simple Shoulder Test (SST) Score 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Simple Shoulder Test (SST) Score 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Simple Shoulder Test (SST) Score 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Visual Analogue Score (VAS) for pain Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: Visual Analogue Score (VAS) for pain 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Visual Analogue Score (VAS) for pain 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Visual Analogue Score (VAS) for pain 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Magnetic Resonance Imaging (MRI) proximal humeral bone quality Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: Magnetic Resonance Imaging (MRI) proximal humeral bone quality Post-op
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Strength Assessment Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: Strength Assessment 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Strength Assessment 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Strength Assessment 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Range of motion Pre-op
timeFrame: To be collected within six months pre-operatively.
measure: Range of motion 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Range of motion 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Range of motion 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
Other outcomes:
measure: Serum Hormone Measurement Surgery
timeFrame: To be collected at the time of surgery.
measure: Luteinizing Hormone Measurement Surgery
timeFrame: To be collected at the time of surgery.
measure: Serum Hormone Measurement 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Luteinizing Hormone Measurement 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Pill Count Surgery
timeFrame: To be collected at the time of surgery.
measure: Pill Count 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Pill Count 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Pill Count 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
measure: Averse Event Assessment Surgery
timeFrame: To be collected at the time of surgery.
measure: Averse Event Assessment 6 weeks
timeFrame: To be collected at six weeks (±2 weeks) post-operatively.
measure: Averse Event Assessment 12 weeks
timeFrame: To be collected at 12 weeks (±2 weeks) post-operatively.
measure: Averse Event Assessment 6 months
timeFrame: To be collected at 6 months (±4 weeks) post-operatively.
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: