Muscle Quality and Percentage of Fat Following a Lower Limb Injury

Longitudinal Evaluation of Muscle Quality in Patients With Fractures - A Prospective Observational Study

The aim of the study is to longitudinally evaluate patient muscle quality in trauma patients with bed rest or altered weight-bearing with the help of a consumer approved non-proprietary muscle impedance-measuring device. Secondary objectives are to identify patient characteristics or treatment protocols that are predictive of poor muscle quality.

Study Overview

• Status: Unknown
• Conditions: Lower Limb Injury; Injury Trauma
• Intervention / Treatment: Device: Electrical Impedance Myography unit or "EIM"

Detailed Description

The study investigators will identify eligible patients through patient consultations from the Emergency Room. There are 100 patients expected to be enrolled in the study. This study will be carried out at the Montreal General Hospital. Inclusion criteria include patients that have had a trauma requiring admission to orthopedic surgery, that have the ability and willingness to participate that were in a steady state medical condition before trauma.

Although the study investigators may discuss the study with the patient, the consent and enrolment will be performed exclusively by the study assistant who is not directly implicated in the patient's care.

This is an observational study, therefore, there will be no randomization and no study intervention.

The following baseline patient characteristics will be recorded for each enrolled participant: age, sex, occupation, smoker, medical comorbidities, AO classification of the fractures and muscle trauma, the date of the injury and date of the surgery if performed.

A consumer approved non-proprietary muscle impedance-measuring device (Electrical Impedance Myography unit or "EIM") will be applied to the muscle groups of interest. The device is self-contained, battery-powered and certified for use on humans. When applied to the skin, a very weak electrical current is passed between the outer two electrodes. This current is high frequency and alternating in nature. As the current moves through the skin, the subcutaneous fat and the muscle, it loses a little bit of energy due to the resistance of the tissue and this change is then measured. This will be done as soon as possible after the trauma and admission during a daytime visit. The EIM will be used every two days until discharge or the patient has reached a recovery plateau in a physical rehabilitation program. Patients' muscle quality will also be measured at each follow-up visit for 100 weeks and patients will be asked to complete two questionnaires.

Each patient will have a unique identification number used to link the patient information, device and data together.

It is expected for most patients to have decreasing muscle quality and increasing fat percentage as a result of deconditioning. There is no longitudinal data on the time period over which this would occur. There is also little data on how recovery occurs after the period of healing.

This study utilizes new technology that permits objective insight into the post-operative period by providing qualitative measurements. It has been used previously in clinical studies on patients with neuromuscular degenerative disease with reproducible and consistent results. The research team anticipates being able to pinpoint specific targets for mobilization goals and rehabilitation techniques depending on the time frame and muscle groups involved with deconditioning.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Recruiting
      • McGill University Health Centre
      • Contact: Mary Amedeo; Phone Number: 43386 514-934-1934; Email: Mary.Amedeo@MUHC.MCGILL.CA
      • Principal Investigator: Edward J Harvey, MDCM, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any adult patient admitted at the Montreal General Hospital for orthopedic surgery because of a lower limb injury preventing them to walk without aid for a certain time.

Description

Inclusion Criteria:

• Trauma requiring admission to orthopedic surgery because of a lower limb injury
• Ability and willingness to participate
• Steady state medical condition before trauma

Exclusion Criteria:

• Age <18
• Pre-existing condition that caused pain or limited weight-bearing on either lower extremity before sustaining trauma (for example the use of walking aids)
• Pre-existing medical conditions that will confound the study outcomes (muscle conditions) and are known to prevent return to function
• Pregnancy
• Implanted electrical device such as heart pacemakers

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Quality	The muscle quality number given by the device is a number given by the company making the device with an arbitrary standard.	Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury
Percentage of Fat Measurement	The percentage of fat is given by the device	Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Edward Harvey, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Orthopedic trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries
• Other Study ID Numbers: 15-056-MUHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will share the results from the collected data in a publication. However, we will not share individual participant data for reasons of confidentiality.