Muscle Quality and Percentage of Fat Following a Lower Limb Injury

NCT03578705 | Unknown

• 1 other identifier: 15-056-MUHC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Limb Injury; Injury Trauma

Keywords

Orthopedic trauma

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Electrical Impedance Myography unit or "EIM" DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

MeSH Terms

Conditions

Leg Injuries; Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Edward Harvey, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Amedeo

CONTACT

514-934-1934

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: July 6, 2018
• Study Start: March 15, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)