Lower Limb InjuryNCT03578705
Muscle Quality and Percentage of Fat Following a Lower Limb Injury
An observational study of Lower Limb Injury and Injury Trauma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Injury, Injury Trauma
- What is being tested?
- Electrical Impedance Myography unit or "EIM"
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2016to 31 Dec 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Trauma requiring admission to orthopedic surgery because of a lower limb injury
- Ability and willingness to participate
- Steady state medical condition before trauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mary Amedeo contact
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Mary Amedeo, 514-934-1934 ext. 43386, mary.amedeo@muhc.mcgill.ca
Edward J Harvey, MDCM, FRCSC
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Limb Injury, Injury Trauma
- Being tested
- Electrical Impedance Myography unit or "EIM"
- Keywords
- Orthopedic trauma
- Medical subject headings
- Leg Injuries, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Myography unit or "EIM"Device
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start15 Mar 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Harvey, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Edward Harvey, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578705
- Sponsor's protocol ID
- 15-056-MUHC
- Status last verified
- May 2020
- First submitted
- 2 Aug 2017
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will share the results from the collected data in a publication. However, we will not share individual participant data for reasons of confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Muscle Quality in Patients With Fractures - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03578705
- Acronym / sponsor ID
- 15-056-MUHC
- Conditions
- Lower Limb Injury, Injury Trauma
- Keywords
- Orthopedic trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Trauma requiring admission to orthopedic surgery because of a lower limb injury
- Ability and willingness to participate
- Steady state medical condition before trauma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance Myography unit or "EIM" | Device | – |
Primary outcome
Change in Muscle Quality
Time frame: Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury
The muscle quality number given by the device is a number given by the company making the device with an arbitrary standard.
Percentage of Fat Measurement
Time frame: Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury
The percentage of fat is given by the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No. We will share the results from the collected data in a publication. However, we will not share individual participant data for reasons of confidentiality.
Related trials for Lower Limb Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Amedeo contact
Edward Harvey, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Injury and Injury Trauma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Amedeo (514-934-1934 ext. 43386), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Quality (time frame: Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.