跳至主要内容
临床试验/NCT04105816
NCT04105816撤回不适用

Assessing the Reliability and Validity of Ultrasound to Evaluate Large Muscle Atrophy in the Lower Limbs

Robert Westermann2 个研究点 分布在 1 个国家开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Validity of musculoskeletal ultrasound use

研究概览

简要总结

Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent injury (1)(2).

The current standard methods to assess lower limb muscle atrophy all have their respective limitations. Thigh circumference or isokinetic strength values are indirect measures of atrophy and can be inaccurate. Magnetic resonance imaging (MRI) of muscle cross-sectional area (CSA) is time-consuming and expensive. Computed tomography imaging of muscle CSA is expensive and exposes the patient to radiation (3). For these reasons, none of the current methods are ideal for regular use in the clinic.

Musculoskeletal ultrasound is a promising measurement tool to assess muscle atrophy in postoperative patients. Ultrasound is non-invasive, cost-effective, does not involve radiation, and can give direct images of muscle size (4). Musculoskeletal ultrasound requires further research on its potential as an evaluation tool for postoperative lower limb orthopedic patients-specifically, whether ultrasound is a reliable and valid tool for quadriceps size measurements.

详细描述

Lower limb surgeries, particularly knee surgeries, are prevalent procedures in US orthopedic departments. Many of these procedures require a postoperative period of immobilization, which may be lengthy for surgeries involving ligament reconstruction, fractures, meniscal repairs, or cartilage transplantation. This leg immobilization results in rapid and significant loss of skeletal muscle mass. Even for shorter periods of immobilization, atrophy occurs within as little as 5 days of immobilization in healthy subjects, and the largest extent of post-operative atrophy takes place during the first two weeks of being immobilized (1)(2).

Muscle atrophy can prolong recovery times and directly impact the safety of a patient's return to activity progression. Providers need a reliable, valid method of assessing postoperative muscle atrophy which is cost-effective, safe, and simple to implement in a clinical setting (4). The aim of this study is to demonstrate that ultrasounds are reliable and valid tools for measuring large lower limb stabilizers such as the rectus femoris. Upon proving reliability and validity, we aim to use the ultrasound to track and characterize rectus femoris atrophy after a common lower limb surgical procedure; anterior cruciate ligament (ACL) reconstruction. Success of this validation study would support the use of ultrasound to monitor large muscle atrophy after lower limb orthopedic surgical procedures, and to evaluate the impact of muscle health interventions. Our ultimate research aim is to develop a reliable, valid ultrasound measurement technique to evaluate promising perioperative interventions for attenuation of muscle atrophy following surgical procedures of the knee.

Patients and Methods:

Part I: Ultrasound measurements of the rectus femoris will be obtained in approximately 50 healthy volunteers. Thigh circumference measurements will be taken as well. The ultrasound (US) images will be de-identified with research identifier (ID) only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight. Ultrasounds currently in use at the UIHC Sports Medicine Clinic will be used. Measurements will be made at a point mid-way between the anterior superior iliac spine and the superior border of the patella.

Part II: Following validation in healthy controls, approximately 100 ACL reconstruction patients will be enrolled for a longitudinal study which utilizes the same ultrasound methods and equipment to track their rectus femoris size at a preoperative visit, and during the 6 week, 3 month, and 6 month standard postoperative follow-up visits. Thigh circumference measurements will be taken as well. The ultrasound images will be de-identified with research ID only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight; along with basic survey data on physical therapy adherence. The patients will not incur any cost from the ultrasound testing, and the ultrasound testing will occur at the same clinical location (UIHC Sports Medicine Clinic) as their follow-up visits.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Validity of musculoskeletal ultrasound use

时间窗: 2 weeks

Intra- and inter-rater validity compared to thigh circumference measurements. For inter-rater, intra-rater , and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine validity of the ultrasound measuring device. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.

Reliability of musculoskeletal ultrasound use

时间窗: 2 weeks

Intra- and inter-rater reliability, reliability compared to thigh circumference measurements. For inter-rater, intra-rater reliability, and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine reliability of the ultrasound measuring device and the measuring technique between individual users and between measurements by the same individual. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.

Amount of quadriceps atrophy using musculoskeletal ultrasound following anterior cruciate ligament reconstruction

时间窗: 6 months

Change in the operative leg versus non-operative leg muscle cross sectional area/thickness will be determined. The degree of change in the operative leg versus the non-operative leg will be evaluated for significant differences. The total number of patients with significant differences between their operative and non-operative legs will be recorded for each time point in the study. The mean and median amount of change at each time point in the operative leg versus the non-operative leg will constitute the "amount of quadriceps atrophy" outcome.

次要结局

未报告次要终点

研究者

发起方
Robert Westermann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Robert Westermann

Assistant Professor

University of Iowa

研究点 (2)

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