Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT03578705
Status:
UNKNOWN
Last Update Posted:
2020-05-15
First Post:
2017-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Quality and Percentage of Fat Following a Lower Limb Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Muscle Quality', 'timeFrame': 'Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury', 'description': 'The muscle quality number given by the device is a number given by the company making the device with an arbitrary standard.'}, {'measure': 'Percentage of Fat Measurement', 'timeFrame': 'Every two-day while in bed rest at the hospital and at every follow-up visit up to 100 weeks after injury', 'description': 'The percentage of fat is given by the device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Orthopedic trauma'], 'conditions': ['Lower Limb Injury', 'Injury Trauma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAlthough 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.\n\nThis is an observational study, therefore, there will be no randomization and no study intervention.\n\nThe 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.\n\nA 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.\n\nEach patient will have a unique identification number used to link the patient information, device and data together.\n\nIt 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma requiring admission to orthopedic surgery because of a lower limb injury\n* Ability and willingness to participate\n* Steady state medical condition before trauma\n\nExclusion Criteria:\n\n* Age \\<18\n* Pre-existing condition that caused pain or limited weight-bearing on either lower extremity before sustaining trauma (for example the use of walking aids)\n* Pre-existing medical conditions that will confound the study outcomes (muscle conditions) and are known to prevent return to function\n* Pregnancy\n* Implanted electrical device such as heart pacemakers'}, 'identificationModule': {'nctId': 'NCT03578705', 'briefTitle': 'Muscle Quality and Percentage of Fat Following a Lower Limb Injury', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Longitudinal Evaluation of Muscle Quality in Patients With Fractures - A Prospective Observational Study', 'orgStudyIdInfo': {'id': '15-056-MUHC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electrical Impedance Myography unit or "EIM"', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mary Amedeo', 'role': 'CONTACT', 'email': 'mary.amedeo@muhc.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '43386'}, {'name': 'Edward J Harvey, MDCM, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Mary Amedeo', 'role': 'CONTACT', 'phone': '514-934-1934', 'phoneExt': '43386'}], 'overallOfficials': [{'name': 'Edward Harvey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Edward Harvey', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}