InjuriesARugbyNCT04402567
Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.
An observational study of Injuries, run by Hospital Donación Francisco Santojanni.
Trial summary
The aim of this study was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injuries
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2020to 1 Jun 2020
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male Argentine amateur rugby players of the 2019 season
Who may be able to join
- >18 years
- Participation in more than 80% during training and matches of the competitive season.
- First, intermediate, Pre-intermediate A and Pre-intermediate B categories of the University teams of Córdoba, Old Resian and Los Matreros, belonging to UAR member unions.
Who cannot join
- Lost patient data
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "Showing the Truth": Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.
The aim of this study was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.
Read the detailed description
Introduction:
Currently, Rugby is a sport that is giving priority to the well-being of the player. Players are subjected to high training and match loads exposing them to constant stress that can lead to overload injuries in addition to frequent contact injuries. Despite knowing what the situation is like at the international and national level, the "Unión Argentina de Rugby" lacks conclusive epidemiological data.
Our main purpose was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.
Design:
Observational, descriptive, retrospective and multicenter study.
Participants:
250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos Aires, Córdoba and Rosario) of Argentina.
Methods:
Registration methods were applied according to the consensus of the World Rugby by a single observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs (data collection centers) as well as the number of matches and hours of training were recorded. Medical diagnoses were classified under the rules of the OSIICS classification system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period), the severity (days of absence) and the injury load will be calculated as well as the location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative Declaration.
- Conditions
- Injuries
- Being tested
- No Intervention
- Keywords
- epidemiology, Incidence, Injury severity, Football
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Not Apply
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Incidence
injuries/1000 hours-player
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start20 May 2020 (estimated)
- Primary completion30 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Donación Francisco Santojanni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Andreu, Hospital Donación Francisco Santojanni
- Investigators
- Mauro Andreu, BSc, Study director, Hospital Donación Francisco Santojanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402567
- Sponsor's protocol ID
- HGADFS19052020-01
- Acronym
- ARugby
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Showing the Truth": Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.
- ClinicalTrials.gov ID
- NCT04402567
- Acronym / sponsor ID
- ARugby / HGADFS19052020-01
- Conditions
- Injuries
- Keywords
- epidemiology, Incidence, Injury severity, Football
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital Donación Francisco SantojanniUniversity, hospital or other
- Study start
- 20 May 2020 (estimated)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 27 May 2020 (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 was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.
Detailed description
Introduction:
Currently, Rugby is a sport that is giving priority to the well-being of the player. Players are subjected to high training and match loads exposing them to constant stress that can lead to overload injuries in addition to frequent contact injuries. Despite knowing what the situation is like at the international and national level, the "Unión Argentina de Rugby" lacks conclusive epidemiological data.
Our main purpose was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.
Design:
Observational, descriptive, retrospective and multicenter study.
Participants:
250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos Aires, Córdoba and Rosario) of Argentina.
Methods:
Registration methods were applied according to the consensus of the World Rugby by a single observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs (data collection centers) as well as the number of matches and hours of training were recorded. Medical diagnoses were classified under the rules of the OSIICS classification system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period), the severity (days of absence) and the injury load will be calculated as well as the location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative Declaration.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male Argentine amateur rugby players of the 2019 season
Key inclusion criteria (3 listed)
- >18 years
- Participation in more than 80% during training and matches of the competitive season.
- First, intermediate, Pre-intermediate A and Pre-intermediate B categories of the University teams of Córdoba, Old Resian and Los Matreros, belonging to UAR member unions.
Key exclusion criteria (1 listed)
- Lost patient data
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 |
|---|---|---|
| No InterventionNot Apply | Other | – |
Primary outcome
Injury Incidence
Time frame: 9 months
injuries/1000 hours-player
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mauro Andreu, BSc study director
Hospital Donación Francisco Santojanni
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries, run by Hospital Donación Francisco Santojanni.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Tondelli, BSc (+54 11 68994582, edutondelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury Incidence (time frame: 9 months). 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 27 May 2020.