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

性激素补充和肩袖修复：初步随机试验

• 批准号: 10582463
• 负责人: Peter Chalmers
• 金额: $ 16.91万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10582463
• 关键词: Adverse effects; Aftercare; Age; Agreement; Animals; Appearance; Biology; Clinical; Clinical Trials; Clomiphene; Clomiphene Citrate; Control Groups; Data; Double-Blind Method; Enrollment; Enthesopathies; Estradiol; Estrogen Receptors; Exogenous Hormone Therapy; FDA approved; Failure; Feasibility Studies; Female; Future; Gene Expression; Genetic Polymorphism; Gonadal Steroid Hormones; Gonadotropins; Healthcare Systems; Histologic; Hormonal; Hormones; Human; Hypogonadism; Injury; Intervention; Laboratory Finding; Magnetic Resonance Imaging; Measures; Mus; Musculoskeletal; Operative Surgical Procedures; Outcome; Ovarian Hyperstimulation Syndrome; Pain; Patient Care; Patients; Persons; Pharmaceutical Preparations; Physiological; Pilot Projects; Placebo Control; Placebos; Postoperative Period; Production; Prospective Studies; Questionnaires; Randomized; Research; Research Personnel; Research Proposals; Rotator Cuff; Serum; Shoulder; Shoulder Pain; Side; Source; Standardization; Supplementation; Tendinopathy; Tendon structure; Testing; Testosterone; Time; Tissues; Translating; Visit; Withdrawal; Work; aged; bone; clinical care; compliance behavior; cost; disability; experience; follow-up; gene repair; healing; hormone deficiency; hormone therapy; human male; improved; insight; instrument; interdisciplinary approach; male; men; novel; phase 2 study; pill; pre-clinical; prospective; randomized trial; randomized, clinical trials; randomized, controlled study; receptor; recruit; repaired; response; retention rate; rotator cuff tear; side effect; soft tissue; success

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.

项目摘要/摘要 肩袖撕裂是最常见的肌肉骨骼疾病之一， 变得越来越普遍。这些伤害让美国医疗保健系统损失了50亿美元 每年一次。前瞻性随机对照研究表明，肩袖 修复(RCR)适用于中小型撕裂。执行了超过500,000个RCR 每年在美国。然而，在RCR后，25%的患者未能愈合。 了解如何提高治愈率是成功的关键障碍。有一种近乎普遍的 一致认为，提高肌腱愈合的生物学是提高愈合的关键。我们的 先前的研究表明性激素缺乏(SHD，即性腺功能减退)在RCR中起作用 治愈失败。目前提案中描述的研究是下一步 将我们充满希望和令人信服的临床前和实验室发现转化为改进 RCT患者的临床护理。SHD可以用激素疗法(HT)治疗，这是 使用广泛，耐受性好，价格低廉，并获得FDA批准。因此，我们提议第二阶段。 研究检验初步疗效和可行性。在目标1中，我们将初步估计 通过随机、安慰剂对照、双盲临床试验治疗全身性高血压的疗效。 40-80岁患有SHD的性腺功能低下的男性将被包括在内。术后我们将评估：A。 RCR结果和B.RCR愈合。我们假设结果和愈合情况会更好 高压组明显高于对照组。在目标2中，我们将确定研究的可行性。 RCR环境下的全身性高血压。尽管高血压的临床经验非常丰富，但在 在患有SHD的男性中，几乎没有人在RCR手术中。要确定 未来更大规模、多中心、随机的临床试验的可行性，我们将衡量以下几点 在目标1中描述的研究的背景下：A.招募和保留率，B.患者 依从性、C.荷尔蒙反应和D.不良反应。工作的预期结果 本研究旨在证明高压氧治疗男性高血压的初步疗效和可行性。 正在接受RCR的SHD。如果这种干预是有效和可行的，那么未来，更大，更好- 有动力的、多中心的随机临床试验和更长时间的随访将是有保证的。 这样的研究可以改善RCT患者的治疗，从而减少 严重残疾。