NCT03373084

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

5 years

First QC Date

December 11, 2017

Last Update Submit

October 9, 2024

Conditions

Sport InjuryHamstring Muscle Lesions

Keywords

Magnetic Resonance Imaging (MRI)UltrasoundSportHamstring muscleInjury

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • mapping of hamstring lesions

    at inclusion

  • volumetric analysis of the hamstrings

    at inclusion

Study Arms (1)

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

Other: Magnetic Resonance Imaging (MRI)Other: ultrasoundOther: Self-questionnaire

Interventions

Magnetic Resonance Imaging (MRI)OTHER

Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion

hamstring muscle lesions
ultrasoundOTHER

Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion

hamstring muscle lesions
Self-questionnaireOTHER

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.

hamstring muscle lesions

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletics with thigh injury will be included.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Magnetic Resonance SpectroscopyHigh-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Pascal EDOUARD, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 14, 2017

Study Start

February 14, 2018

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)