Operation Korsband

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Risk Factors for Cruciate Ligament Injuries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05752695
• Other study ID #: 2022-06554-01
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2023
• Source: Linnaeus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate if a detailed and comprehensive survey can identify, explain and prevent the risk factors for ACL injury.

A a new questionnaire has been developed with questions to young athletes who have suffered an anterior cruciate ligament injury. The questionnaire is more detailed and provide more information about how the anterior cruciate ligament injury occurred compared with the questionnaires currently available in the literature. This careful documentation will provide new knowledge and might be used to identify, explain and prevent risk factors that cause young athletes to suffer an anterior cruciate ligament injury.

Description:

Participants will be prospectively recruited at their first physiotherapist clinical session. On this occasion, participants will be asked to fill in a questionnaire regarding injury situation, game or training, sex, age, sport affiliation, level of sport, other aspects of sport such as participation in several teams and junior versus senior games/training. In addition, questions regarding previous injury will also be documented.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

Inclusion Criteria:

• Athlete

• Defined ACL injury

Exclusion Criteria:

• Non athletes

• Younger than 12 years

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Locations

Country	Name	City	State
Sweden	Sofia Ryman Augustsson	Kalmar

Sponsors (2)

Lead Sponsor	Collaborator
Linnaeus University	Kalmar County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total work load	Total hours, per week, of practice and games.	Day 1
Secondary	Number of teams	In team athletes, the number of teams in which the athlete participates.	Day 1
Secondary	Injury situation 1	Question regarding when the injury occurred; training vs game.	Day 1
Secondary	Injury situation 2	Question regarding at what situation the injury occurred (e.g. jump, landing, header duel, defense, attack...)	Day 1
Secondary	Injury situation 3	Question regarding at what time, during a game, the injury occurred; approximate match minute	Day 1
Secondary	Physical well-being	Physical well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'.	Day 1
Secondary	Mental wellbeing	Mental well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'.	Day 1
Secondary	Previous injury	Description of previous injury prior to the ACL injury, such as other injuries to lower extremity or concussion.	Day 1