Fractures in ChildrenNCT05220969
Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
An observational study of Fractures in Children and Apophysitis, run by St Mary's University College at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fractures in Children, Apophysitis, Muscle Strain
- What is being tested?
- Total Genotype Risk Score
- How many people
- 95 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Dec 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Elite male football players aged 12-40
Who may be able to join
- Elite male football players
Who cannot join
- Female
- non-elite
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Fulham Football Club
London, New Malden, KT3 6PT
St Mary's University, Twickenham
London, Twickenham, TW1 4SX
About this study
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.
- Conditions
- Fractures in Children, Apophysitis, Muscle Strain, Ligament Injury, Tendon Injuries, Genetic Predisposition
- Being tested
- Total Genotype Risk Score
- Medical subject headings
- Sprains and Strains, Tendon Injuries, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Genotype Risk ScoreGenetic
A total genotype risk score has been generated based on the results of previously observed genetic association studies
| Study group | Role | What they receive |
|---|---|---|
| Elite male youth footballers | Elite male youth footballers at an English championship / premier league football club Receives: Genetic: Total Genotype Risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Injury Risk
Did the risk of fracture differ between total genotype risk score categories? was this affected by maturation?
Measured: 8 Years
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?
Measured: 8 Years
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?
Measured: 8 Years
Tendon Injury Risk
Did the risk of tendon injury differ between total genotype risk score categories? was this affected by maturation, and loading?
Measured: 8 Years
Ligament Injury Risk
Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?
Measured: 8 Years
Apophysitis Injury Risk
Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Dec 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- Fulham Football Club
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220969
- Sponsor's protocol ID
- SMEC_2019-20_003
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
- ClinicalTrials.gov ID
- NCT05220969
- Acronym / sponsor ID
- SMEC_2019-20_003
- Conditions
- Fractures in Children, Apophysitis, Muscle Strain, Ligament Injury, Tendon Injuries, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- Fulham Football Club
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elite male youth footballers | – | Genetic: Total Genotype Risk ScoreElite male youth footballers at an English championship / premier league football club |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Elite male football players aged 12-40
Key inclusion criteria (1 listed)
- Elite male football players
Key exclusion criteria (2 listed)
- Female
- non-elite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Genotype Risk ScoreA total genotype risk score has been generated based on the results of previously observed genetic association studies | Genetic | Elite male youth footballers |
Primary outcome
Fracture Injury Risk
Time frame: 8 Years
Did the risk of fracture differ between total genotype risk score categories? was this affected by maturation?
Non-Contact Injury Risk
Time frame: 8 Years
Did the risk of non-contact injury differ between total genotype risk score categories? was this affected by maturation, and loading?
Non-Contact Muscle Injury Risk
Time frame: 8 Years
Did the risk of non-contact muscle injury differ between total genotype risk score categories? was this affected by maturation, and loading?
Tendon Injury Risk
Time frame: 8 Years
Did the risk of tendon injury differ between total genotype risk score categories? was this affected by maturation, and loading?
Ligament Injury Risk
Time frame: 8 Years
Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?
Apophysitis Injury Risk
Time frame: 8 Years
Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures in Children and Apophysitis, run by St Mary's University College at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Injury Risk (time frame: 8 Years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.