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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05220969
Other study ID # SMEC_2019-20_003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date July 31, 2021

Study information

Verified date January 2022
Source St Mary's University College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A total genotype risk score was generated based on the findings of previous research for non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture injury and apophysitis injury. This score was then compared with the incidence of injury between those with high, medium and low risk scores for each injury. The influence of different rates of growth, stages of physical maturation and loading exposure were then also included in the risk model to see if any interaction effects could be observed between genetic risk score and susceptibility to injury in different categories of growth, maturation and loading exposure.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 12 Years to 40 Years
Eligibility Inclusion Criteria: - Elite male football players Exclusion Criteria: - Female - non-elite

Study Design


Intervention

Genetic:
Total Genotype Risk Score
A total genotype risk score has been generated based on the results of previously observed genetic association studies

Locations

Country Name City State
United Kingdom Fulham Football Club London New Malden
United Kingdom St Mary's University, Twickenham London Twickenham

Sponsors (2)

Lead Sponsor Collaborator
St Mary's University College Fulham Football Club

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fracture Injury Risk Did the risk of fracture differ between total genotype risk score categories? was this affected by maturation? 8 Years
Primary Non-Contact Injury Risk Did the risk of non-contact injury differ between total genotype risk score categories? was this affected by maturation, and loading? 8 Years
Primary Non-Contact Muscle Injury Risk Did the risk of non-contact muscle injury differ between total genotype risk score categories? was this affected by maturation, and loading? 8 Years
Primary Tendon Injury Risk Did the risk of tendon injury differ between total genotype risk score categories? was this affected by maturation, and loading? 8 Years
Primary Ligament Injury Risk Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation? 8 Years
Primary Apophysitis Injury Risk Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation? 8 Years
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