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

项目总结/摘要 肩袖撕裂（RCT）是最常见的肌肉骨骼疾病， 变得越来越普遍。这些伤害花费了美国医疗保健系统50亿美元 每年。前瞻性随机对照研究表明，肩袖 修复（RCR）适用于小型和中型撕裂。进行了超过500，000次RCR 每年在美国。然而，在RCR后，>25%的患者未能愈合。 了解如何改善愈合是成功的关键障碍。几乎所有的 一致认为改善肌腱愈合的生物学是改善愈合的关键。我们 先前的研究表明，性激素缺乏症（SHD，即性腺功能减退症）在RCR中起作用 治愈失败目前提案中所述的研究是实现以下目标的下一步： 将我们有前途和令人信服的临床前和实验室发现转化为改进的 临床护理与RCT。SHD可以用激素疗法（HT）治疗， 广泛使用，耐受性良好，价格低廉，并获得FDA批准。因此，我们建议第二阶段 研究，以测试初步的功效和可行性。在目标1中，我们将估计初步 通过一项随机、安慰剂对照、双盲临床试验评估全身性HT的疗效。 将纳入患有SHD的40-80岁性腺功能减退男性。术后我们将评估：A。 RCR结局和B. RCR愈合。我们假设结果和愈合会更好， HT组与对照组比较差异有统计学意义。在目标2中，我们将确定研究的可行性 在RCR环境中的全身HT。尽管在临床上有大量的HT经验， 在患有SHD的人类男性中，在RCR手术的环境中几乎没有。确定 未来更大规模、多中心、随机临床试验的可行性，我们将测量以下内容 在目标1：A所述研究的范围内。招聘和保留率，B。患者 顺应性C.激素反应和D.不良影响工作的预期成果 提出的是HT在人类男性中的初步疗效和可行性的证明， 接受RCR的SHD。如果这种干预是有效和可行的，那么未来，更大的，以及- 有把握的，多中心的随机临床试验和更长的随访将是必要的。 这样的研究可以改善RCT患者的治疗，从而减少 严重残疾。

Project Summary/Abstract Rotator cuff tears (RCTs) are among the most common musculoskeletal complaints and are becoming more common. These injuries cost the US health care system $5 billion dollars annually. Prospective randomized and controlled studies have demonstrated that rotator cuff repair (RCR) is indicated for small- and medium-sized tears. Over 500,000 RCRs are performed in the US annually. However, after RCR, healing fails to occur in >25% of patients. Understanding how to improve healing is a critical barrier to success. There is near universal agreement that improving the biology of tendon healing is the key to improving healing. Our prior research suggests Sex Hormone Deficiency (SHD, i.e. hypogonadism) plays a role in RCR healing failure. The research described in the current proposal is the next step towards translating our promising and compelling preclinical and laboratory findings into improved clinical care of patients with RCTs. SHD can be treated with hormone therapy (HT), which is widely utilized, well-tolerated, inexpensive, and FDA approved. Thus, we propose a phase II study to test preliminary efficacy and feasibility. Within aim 1, we will estimate the preliminary efficacy of systemic HT through a randomized, placebo-controlled, double-blinded clinical trial. Hypogonadal men aged 40-80 with SHD will be included. Postoperatively we will evaluate: A. RCR outcomes and B. RCR healing. We hypothesize that outcomes and healing will be better in the HT group than the control group. Within aim 2, we will determine the feasibility of studying systemic HT in the setting of RCR. Although there is extensive clinical experience with HT in human males with SHD, there is almost none in a setting of RCR surgery. To determine the feasibility of a future, larger, multi-center, randomized clinical trial, we will measure the following within the context of the study described in Aim 1: A. recruitment and retention rates, B. patient compliance, C. hormonal response, and D. adverse effects. The expected outcome of the work proposed is demonstration of the preliminary efficacy and feasibility of HT in human males with SHD undergoing RCR. If this intervention is effective and feasible, then a future, larger, well- powered, multi-centered randomized clinical trial with longer follow-up would be warranted. Such a study could improve the treatment of people with RCTs, thereby decreasing a source of significant disability.