Traumatic Knee InjuryNCT04869566
External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
An observational study of Traumatic Knee Injury, run by Linnaeus University at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Knee Injury
- How many people
- 329 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2020to 1 Aug 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden, will be contacted and introduced to the study through email. The team coach at each school will distribute a web-based form to the athletes during their first, second or third year of the high-school period by email or through the school's intra-net system. We estimate that approximately 300 youth athletes (50% women) will be included. From the included participants, ahtletes with traumatic knee injury will be included for furhter analysis.
Who may be able to join
- Male and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball
Who cannot join
- Traumatic knee injury prior to sport high school.
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.
The present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.
- Conditions
- Traumatic Knee Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Athletes with traumatic knee injury | Youth athletes, aged 16-19, with traumatic knee injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that had occurred an injury during the last year
Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.
Measured: 12 months
Number of participants with one ore several mental stressors related to environmental and social conditions
Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Knee InjuryStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Ryman Augustsson, Linnaeus University
- Investigators
- Sofia Ryman Augustsson, PhD, Principal investigator, sofia.rymanaugustsson@lnu.se
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869566
- Sponsor's protocol ID
- 2019-02609
- Other IDs
- 2019
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
- ClinicalTrials.gov ID
- NCT04869566
- Acronym / sponsor ID
- 2019-02609
- Conditions
- Traumatic Knee Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 3 May 2021 (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.
The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.
The present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes with traumatic knee injury | – | –Youth athletes, aged 16-19, with traumatic knee injury |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden, will be contacted and introduced to the study through email. The team coach at each school will distribute a web-based form to the athletes during their first, second or third year of the high-school period by email or through the school's intra-net system. We estimate that approximately 300 youth athletes (50% women) will be included. From the included participants, ahtletes with traumatic knee injury will be included for furhter analysis.
Key inclusion criteria (1 listed)
- Male and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball
Key exclusion criteria (2 listed)
- Traumatic knee injury prior to sport high school.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants that had occurred an injury during the last year
Time frame: 12 months
Data on injury are collected retrospectively using a web-designed (SurveyMonkey®) registration form.
Number of participants with one ore several mental stressors related to environmental and social conditions
Time frame: 12 months
Mental stressors, such as club exchange, changed game system, conflict within the family, examination at school etc will be recorded using a questionnaire.
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 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Sofia Ryman Augustsson, PhD principal investigator
sofia.rymanaugustsson@lnu.se
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Knee Injury, run by Linnaeus University at 1 site in Sweden.
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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Number of participants that had occurred an injury during the last year (time frame: 12 months). The study lists 2 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 22 Sep 2021.