Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- change in structural integrity of the rotator cuff/tendon healing
研究概览
简要总结
This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.
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)
盲法说明
Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for rotator cuff repair
- •failed nonoperative management of chronic, full thickness rotator cuff tears
- •full thickness rotator cuff tear confirmed on MRI
排除标准
- •patients with prior shoulder surgery or prior rotator cuff repair
- •tears larger than 5 cm
- •significant glenohumeral arthritis (Hamada Grade 2 or higher)
- •Untreated diabetes mellitus
- •Pituitary tumor
- •Rheumatoid arthritis
- •Uncontrolled hypertension
- •Congestive heart failure
- •Myocardial infarction within the past 6 months
- •End-stage renal disease
- •Liver enzymes two times the normal value
- •Deep Vein Thrombosis (DVT) within the past 6 months
- •Disorder of the coagulation system
- •Currently taking anticoagulation
- •Claustrophobia
- •Prior or current use of anabolic steroids
- •Chromosomal disorders
- •Prostate cancer
- •Breast cancer
- •Hypercalcemia
- •Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors
- •Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment
- •Any other condition or treatment interfering with completion of the trial
研究组 & 干预措施
Placebo Group
placebo
干预措施: Placebo (Drug)
Treatment Group
Oxandrolone
干预措施: Oxandrolone (Drug)
结局指标
主要结局
change in structural integrity of the rotator cuff/tendon healing
时间窗: baseline to 52 weeks
assessed by MRI, classified based on the Sugaya classification and Goutallier Grade
次要结局
- change in ASES shoulder score(baseline to 104 weeks)
研究者
George F. Hatch
Associate Professor
University of Southern California