Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Quadriceps muscle strength
研究概览
简要总结
This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All racial and ethnic groups
- •Diagnosis of tibial plateau fracture
- •Patients who opt for surgical treatment or non-operative treatment of their fracture
- •Patients who consent to undergoing 3 MRI scans
- •Patients who are willing to follow-up for a minimum of 52 weeks
排除标准
- •Patients younger than 18 years old or older than 65
- •Patients who may be pregnant or may become pregnant in the 52 weeks following injury
- •Patients who have electric, magnetic, or mechanical devices currently implanted
- •Patients who have abnormal ECG results
- •Diagnosis of any additional lower extremity fractures other than tibial plateau
- •Patients who fit the definition of a vulnerable population
结局指标
主要结局
Quadriceps muscle strength
时间窗: One Year
This will be measured by the highest knee-extension torque over six repetitions for each leg.
Muscle Volume
时间窗: One Year
This will be measured by the sum of the CSAs (Cross Sectional Areas) of each image times the thickness (10mm) and interslice gap (10mm) of each section
Cross-sectional area (CSA) calculations
时间窗: 1 Year
From the axial images obtained from the MRI for each leg, outlines of each muscle in the quadriceps femoris muscle group will be traced and used to calculate.
Pain Level
时间窗: One Year
This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)
次要结局
- Isokinetic Knee-Extension Strength Test(One year)