Muscle Quality and Percentage of Fat Following a Lower Limb Injury

Lower Limb Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578705
• Other study ID #: 15-056-MUHC
• Status: Recruiting
• Start date: March 15, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Mary Amedeo
• Phone: 514-934-1934
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injury Trauma
• Leg Injuries
• Lower Limb Injury
• Wounds and Injuries

Intervention

Device:
• Electrical Impedance Myography unit or "EIM"

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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