Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

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 So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more.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.

• American Shoulder and Elbow Surgeons (ASES) Score Pre-op [Срок оценки: To be collected within six months pre-operatively.]
• American Shoulder and Elbow Surgeons (ASES) Score 6 weeks [Срок оценки: To be collected at six weeks (±2 weeks) post-operatively.]
• American Shoulder and Elbow Surgeons (ASES) Score 12 weeks [Срок оценки: To be collected at 12 weeks (±2 weeks) post-operatively.]
• American Shoulder and Elbow Surgeons (ASES) Score 6 months [Срок оценки: To be collected at 6 months (±4 weeks) post-operatively.]
• Simple Shoulder Test (SST) Score Pre-op [Срок оценки: To be collected within six months pre-operatively.]
• Simple Shoulder Test (SST) Score 6 weeks [Срок оценки: To be collected at six weeks (±2 weeks) post-operatively.]
• Simple Shoulder Test (SST) Score 12 weeks [Срок оценки: To be collected at 12 weeks (±2 weeks) post-operatively.]
• Simple Shoulder Test (SST) Score 6 months [Срок оценки: To be collected at 6 months (±4 weeks) post-operatively.]
• Visual Analogue Score (VAS) for pain Pre-op [Срок оценки: To be collected within six months pre-operatively.]
• Visual Analogue Score (VAS) for pain 6 weeks [Срок оценки: To be collected at six weeks (±2 weeks) post-operatively.]
• Visual Analogue Score (VAS) for pain 12 weeks [Срок оценки: To be collected at 12 weeks (±2 weeks) post-operatively.]
• Visual Analogue Score (VAS) for pain 6 months [Срок оценки: To be collected at 6 months (±4 weeks) post-operatively.]