Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Magnetic Resonance Imaging (MRI) tendon healing Post-op
研究概览
简要总结
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.
详细描述
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 So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control
All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the control group, these will be placebo. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery.
干预措施: Rotator Cuff Repair (Procedure)
Clomiphene
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. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery.
干预措施: Clomiphene Citrate (Drug)
Clomiphene
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. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery.
干预措施: Rotator Cuff Repair (Procedure)
结局指标
主要结局
Magnetic Resonance Imaging (MRI) tendon healing Post-op
时间窗: To be collected at 6 months (±4 weeks) post-operatively.
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.
次要结局
- Simple Shoulder Test (SST) Score Pre-op(To be collected within six months pre-operatively.)
- Simple Shoulder Test (SST) Score 6 months(To be collected at 6 months (±4 weeks) post-operatively.)
- Visual Analogue Score (VAS) for pain Pre-op(To be collected within six months pre-operatively.)
- American Shoulder and Elbow Surgeons (ASES) Score 6 months(To be collected at 6 months (±4 weeks) post-operatively.)
- Simple Shoulder Test (SST) Score 6 weeks(To be collected at six weeks (±2 weeks) post-operatively.)
- Visual Analogue Score (VAS) for pain 6 months(To be collected at 6 months (±4 weeks) post-operatively.)
- Visual Analogue Score (VAS) for pain 6 weeks(To be collected at six weeks (±2 weeks) post-operatively.)
- American Shoulder and Elbow Surgeons (ASES) Score Pre-op(To be collected within six months pre-operatively.)
- Strength Assessment 12 weeks(To be collected at 12 weeks (±2 weeks) post-operatively.)
- American Shoulder and Elbow Surgeons (ASES) Score 6 weeks(To be collected at six weeks (±2 weeks) post-operatively.)
- American Shoulder and Elbow Surgeons (ASES) Score 12 weeks(To be collected at 12 weeks (±2 weeks) post-operatively.)
- Simple Shoulder Test (SST) Score 12 weeks(To be collected at 12 weeks (±2 weeks) post-operatively.)
- Visual Analogue Score (VAS) for pain 12 weeks(To be collected at 12 weeks (±2 weeks) post-operatively.)
- Strength Assessment Pre-op(To be collected within six months pre-operatively.)
- Strength Assessment 6 months(To be collected at 6 months (±4 weeks) post-operatively.)
- Range of motion 6 weeks(To be collected at six weeks (±2 weeks) post-operatively.)
- Range of motion 12 weeks(To be collected at 12 weeks (±2 weeks) post-operatively.)
- Magnetic Resonance Imaging (MRI) proximal humeral bone quality Pre-op(To be collected within six months pre-operatively.)
- Range of motion Pre-op(To be collected within six months pre-operatively.)
- Magnetic Resonance Imaging (MRI) proximal humeral bone quality Post-op(To be collected at 6 months (±4 weeks) post-operatively.)
- Strength Assessment 6 weeks(To be collected at six weeks (±2 weeks) post-operatively.)
- Range of motion 6 months(To be collected at 6 months (±4 weeks) post-operatively.)
研究者
Peter Chalmers
Associate Professor, Department of Orthopaedic Surgery
University of Utah