Ultrasound for Rectus Femoris Measurement

NCT04105816 | Withdrawn FDA Device

• 1 other identifier: 201906778
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Atrophy, Proximal; Muscle Atrophy; ACL Tear; Quadriceps Muscle Atrophy

Keywords

rectus femoris; ACL repair recovery; musculoskeletal ultrasound; quadriceps atrophy; validation

Outcome Measures

Primary Outcomes (3)

• Validity of musculoskeletal ultrasound use

  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.

  2 weeks

• Reliability of musculoskeletal ultrasound use

  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.

  2 weeks

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

  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.

  6 months

Study Arms (2)

Adult Healthy Controls

PLACEBO COMPARATOR

Subjects included in part I of this study will be healthy adult volunteers with no known musculoskeletal injury. Exclusion criteria will be those with identified musculoskeletal injury, non-English speaking persons, and women who are pregnant.

Device: 892.1550 Ultrasonic pulsed doppler imaging system; Diagnostic Test: Thigh circumference measurement

Adult ACL Reconstruction Patients

EXPERIMENTAL

Subjects included in part II of the study will be adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa. Exclusion criteria will be non-English speaking persons, women who are pregnant, patients undergoing multi-ligament repair, patients undergoing ACL reconstruction revision, patients undergoing concomitant cartilage or meniscal repair procedures, and patients undergoing bilateral ACL reconstructions.

Device: 892.1550 Ultrasonic pulsed doppler imaging system; Diagnostic Test: Thigh circumference measurement

Interventions

892.1550 Ultrasonic pulsed doppler imaging system DEVICE

Use of the ultrasound to measure quadriceps volume

Adult ACL Reconstruction Patients; Adult Healthy Controls

Thigh circumference measurement DIAGNOSTIC_TEST

Tape measure used to measure thigh circumference of all participating patients in the study at the same visit in which they receive ultrasound measurements of thigh muscles.

Adult ACL Reconstruction Patients; Adult Healthy Controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults with no known musculoskeletal injury

You may not qualify if:

• Those with identified musculoskeletal injury
• Non-English speaking persons
• Women who are pregnant. Graduate medical education residents will be from the
• Part 2 -
• Adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa
• non-English speaking persons
• women who are pregnant
• patients undergoing multi-ligament repair
• patients undergoing ACL reconstruction revision
• patients undergoing concomitant cartilage or meniscal repair procedure
• patients undergoing bilateral ACL reconstructions

Sponsors & Collaborators

• Robert Westermann: lead

Study Sites (1)

University of Iowa Sports Medicine

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Robert Westermann, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 26, 2019
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)