- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373084
Imaging Location of Hamstring Muscle Lesions in Sport and Relationships With Injury Mechanism. (HAMMER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-Étienne, France
- CHU Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- To be recreational sportsmen, competitions, amateurs, high-level or professional
- Aged 18 to 50 years
- Perform an Magnetic Resonance Imaging (MRI) or an ultrasound of the thigh in the context of the suspicion of an acute hamstring muscle injury
- Injury during sport since less 21 days old.
Exclusion Criteria:
- a history of surgery of the anterior cruciate ligament with removal of the transplant in the posterior compartment of the thigh
- an antecedent of surgery of the thigh.
- inability to understand the French language for completing the self-questionnaire
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
hamstring muscle lesions
Patients with hamstring muscle lesions in sport will be included.
As usual practice they will have Magnetic Resonance Imaging (MRI) or ultrasound, and will answer to self-questionnaire
|
Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
Self-questionnaire will be completed by patient.
In this questionnaire patients will describe the circumstances of the injury and their personal characteristics and level of sporting practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
location of the lesion of injury
Time Frame: at inclusion
|
Correlation between location of the lesion and mechanism of onset of injury.
Location of the lesion will be measured by Magnetic Resonance Imaging (MRI) or ultrasound results.
For location of the lesion, it is a combination of the injured muscle, damaged tissue and the area in the posterior compartment of the thigh.
|
at inclusion
|
|
mechanism of onset of injury
Time Frame: at inclusion
|
Correlation between location of the lesion and mechanism of onset of injury. Location of the lesion will be measured by Magnetic Resonance Imaging (MRI) or ultrasound results. Mechanism of onset of injury will be check by self-questionnaire. |
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mapping of hamstring lesions
Time Frame: at inclusion
|
Analyzed of mapping of hamstring lesions with Magnetic Resonance Imaging (MRI) / ultrasound. Compare the MRI and ultrasound maps and the performance of the two means to determine the location of the lesion. |
at inclusion
|
|
volumetric analysis of the hamstrings
Time Frame: at inclusion
|
A standardization of the images to allow a better comparison between individuals
|
at inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pascal EDOUARD, MD, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708231
- ANSM (Other Identifier: 2021-A02121-40)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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