Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Harris Hip Score
研究概览
简要总结
This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement. Subjects will be male patients > 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease. All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo. A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects. Testosterone therapy will be administered once to each patient at 2 weeks before surgery. The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients
- •50 years of age and older
- •Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.
排除标准
- •History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer free
- •History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
- •History of deep vein thrombosis (DVT)
- •Presence of Factor V Leiden (as seen in labs)
- •Presence of Protein S Deficiency (as seen in labs)
- •History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
- •Liver disease (as viewed by liver function tests)
- •Testosterone free level greater than 10pg/mL
- •Hematocrit >51%; PSA >= 3ng/mL.
研究组 & 干预措施
Testosterone Therapy
干预措施: Testosterone Therapy (Drug)
No Testosterone Therapy
干预措施: No Testosterone Therapy (Other)
结局指标
主要结局
Harris Hip Score
时间窗: 1 year
patient-reported outcome measure
Forgotten Joint Score
时间窗: 1 year
patient-reported outcome measure
次要结局
- Visual Analog Scale(1 year)
- Patient Satisfaction (reported from questionnaire)(1 year)