Prevention of knee injury in handball
| ISRCTN | ISRCTN94413028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94413028 |
| Secondary identifying numbers | 2022-04 |
- Submission date
- 06/04/2022
- Registration date
- 22/07/2022
- Last edited
- 22/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Handball is associated with a high risk of knee injury that needs to be reduced. The purpose of this study is to show how an injury-prevention programme effectively reduces knee injury in adult and adolescent handball players.
Who can participate?
Any active handball player aged 14 years or older in any of the German-speaking handball leagues with at least one competitive match during the interventional season 2022-23
What does the study involve?
Teams register for the study and are allocated randomly in either the intervention arm or control arm. Players of the intervention group regularly participate in an injury-prevention programme for one season. Handball exposure and sustained injuries are documented for both groups on a regular basis.
What are the possible benefits and risks of participating?
Possible benefits of the intervention arm are the reduction of knee injury or reduction in prevalence/intensity of overuse knee injury symptoms. No risk are reported to date for neuromuscular injury prevention programmes.
Where is the study run from?
1. Dpt. of Orthopaedic Surgery, König-Ludwig-Haus, University Würzburg, Würzburg, Germany
2. Dpt. of Trauma, Hand, Plastic and Reconstructive Surgery, University Medical Center Wuerzburg, Germany
When is the study starting and how long is it expected to run for?
March 2019 to June 2023
Who is funding the study?
Bundesinstitut für Sportwissenschaft / German Federal Institute for Sports Sciences
Who is the main contact?
Dr Leonard Achenbach
leonardachenbach@gmail.com
Contact information
Principal Investigator
Brettreichstraße 11
Würzburg
97074
Germany
 ORCID ID |
0000-0002-9053-0624 |
|---|---|
| Phone | +49 931803-0 |
| l-achenbach.klh@uni-wuerzburg.de |
Study information
| Study design | Prospective cluster-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Prevention of acute severe knee injury in handball: a cluster randomised controlled trial |
| Study objectives | The purpose of this study is to show how an injury prevention programme specific for knee effectively reduces acute knee injury in handball players |
| Ethics approval(s) | Approved 13/03/2019, Ethical committee of the University of Regensburg (D-93040 Regensburg, Germany; +49 (0)941 943 5370; ethikkommission@klinik.uni-regensburg.de), ref: 15-101-0137 |
| Health condition(s) or problem(s) studied | Musculoskeletal knee injury |
| Intervention | Intervention arm: teams are given a neuromuscular training programme. this should be implemented at least twice per week during the whole course of the season Control arm: teams proceed with their normal training without any instructions Total duration: season 2022/23 (July 2022 - May 2023) Injuries of all participating teams/players are assessed on a regular basis (every six weeks) during the whole season by means of standardised injury questionnaires. Stratified cluster randomisation is carried out and a 1:1 randomisation in both arms is scheduled. Stratification is based on sex (male/female), age (under-15/under-17/under-19/senior) and level of professionalism (league 1-3/4-6/7 or lower). |
| Intervention type | Behavioural |
| Primary outcome measure | Number of new acute severe knee injuries sustained per 1000 h of handball throughout the intervention season, such as intraarticular fracture, patella dislocation, rupture of the collateral or cruciate ligament, meniscus tear, cartilage injury or any injury resulting in absence from training session or match for more than 28 days. Measured by online questionnaires and personal contact of the study team with the handball teams. |
| Secondary outcome measures | 1. Injury mechanism of knee injuries (contact, indirect contact, non-contact) throughout the intervention season, measured by online questionnaires and personal contact of the study team with the handball teams 2. Prevalence of overuse knee injury throughout the intervention season, measured by online questionnaires and personal contact of the study team with the handball teams |
| Overall study start date | 13/03/2019 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Sample size was calculated based on the primary endpoint of incidence of acute severe injury to the knee in handball athletes within one season. The incidence of 0.33 per 1000h was based on the incidence reported in the recent literature. The study aimed to achieve a reduction to 0.04 per 1000h. To achieve this effect with a power of 80%, an estimated intraclass correlation coefficient of 0.10, and an average team size of 10 athletes with an error type 1 of maximum 5%, 30 teams per group and thus a total of 60 teams with n=662 athletes have to be included. |
| Key inclusion criteria | 1. Active male or female handball player in any of the German-speaking handball leagues with at least one competitive match during the interventional season 2022/23 2. Aged 14 years or older |
| Key exclusion criteria | 1. Inability to understand German 2. No signed consent |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 30/05/2023 |
Locations
Countries of recruitment
- Austria
- Germany
- Switzerland
Study participating centres
Würzburg
97080
Germany
Würzburg
97074
Germany
Sponsor information
Hospital/treatment centre
Brettreichstr. 6
Würzburg
97080
Germany
| Phone | +49 931201-0 |
|---|---|
| fehske_k@ukw.de |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- German Federal Institute of Sport Science, BISp
- Location
- Germany
Results and Publications
| Intention to publish date | 30/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
14/04/2022: Trial's existence confirmed by the ethical committee of the University of Regensburg.
