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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03373084
Other study ID # 1708231
Secondary ID ANSM
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2018
Est. completion date July 2026

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Pascal EDOUARD, MD
Phone (0)477127985
Email pascal.edouard@univ-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hamstring muscle injuries are a common pathology in sports mainly present in sprint and acceleration sports, accounting for about 12% of all football injuries. Because of their frequency, risk of reinjury and financial cost, they can be considered as a public health problem. Improving knowledge of the pathophysiology of hamstring muscle injury appears to be a relevant research focus for prevention purposes.


Description:

This study is a cohort of athletes in the context of suspicion of hamstring muscle injuries.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2026
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Other:
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
ultrasound
Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
Self-questionnaire
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.

Locations

Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary location of the lesion of injury 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
Primary mechanism of onset of injury 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 mapping of hamstring lesions 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
Secondary volumetric analysis of the hamstrings A standardization of the images to allow a better comparison between individuals at inclusion
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