Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Manual Measurements of the Quadriceps
研究概览
简要总结
The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.
详细描述
This is an in vivo study using serial IM testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee replacement, ACL reconstruction/revision, meniscal allograft transplantation and articular cartilage paste grafting. The design is a randomized, controlled, double blind, longitudinal study of intra-muscular injections of testosterone versus saline control. Pre-operative and post-operative assessments will include: serial MRIs and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS. Blood analysis will be performed for therapeutic assessment and safety. The participant will receive two testosterone undeconate injections, once during their pre-operative visit and once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental group at all time points may identify differences in participant response to testosterone injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the participant and analyzing MRI Radiologist will be blind.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males age 18-
- •Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.
排除标准
- •Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
- •Men with BMI > 30 and Type I or II diabetes diagnosis
- •Men prone to deep vein thrombosis or sleep apnea.
- •Men with pre-existing hematocrit abnormalities.
- •Men with pre-existing cardiac, renal, hepatic disease.
- •Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.
- •Men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate).
- •Subject's unable or unwilling to comply with the protocol.
- •Subject's unable to provide informed consent.
- •Subject's unable to understand verbal and/or written English.
研究组 & 干预措施
Testosterone Group
Participants receiving two IM Testosterone injections.
干预措施: Aveed 750 MG in 3 ML IM Injection (Drug)
Control Group
Participants receiving two IM Normal Saline Injections.
干预措施: Normal Saline 3 ML IM Injection (Other)
结局指标
主要结局
Change in Manual Measurements of the Quadriceps
时间窗: Pre-operative and 1, 3, and 6 months post-operative
Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.
Change in MRI Cross Sectional Area of the Quadriceps
时间窗: Pre-operative and 1, 3, and 6 months post-operative
T1 Axial and Sagittal planes will be obtained using a ONI 1.0T extremity MRI. Axial Cross sectional Area (cm\^2) will be measured of the Quadriceps muscle.
次要结局
- Change in Knee Pain and Function Survey, KOOS(Pre-operative and 1, 3, and 6 months post-operative)