Reference Values for Knee Rotational Amplitudes in a Population of Athletes

Not yet recruiting

• Conditions: Knee Ligament Injury

• Registration Number: NCT07013019
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Brief Summary

Rupture of the anterior cruciate ligament (ACL) is a frequent and disabling injury in pivot sports, leading to knee laxity and instability, reduced performance and an increased risk of early osteoarthritis. The risk is 2 to 8 times higher in women, linked to greater ligament laxity and a different quadriceps/hamstring muscle ratio post-puberty.

To assess knee laxity and the degree of ligament damage, anterior tibial translation (of the tibia below the femur) is usually measured. This translation is symmetrical and varies between 3 and 10 mm depending on the individual (natural laxity). It is increased in cases of ACL damage.

Measuring tibial rotation is also of interest in this context. Studies show that the ACL plays a crucial role in controlling internal and external tibial rotation, especially during low-flexion movements (between 10° and 30°). ACL rupture also significantly increases this rotation, aggravating knee instability.

It therefore seems important to study both tibial rotation and tibial translation to assess knee laxity. Combining these two measurements seems to improve diagnostic accuracy. This multifactorial approach could provide additional information on biomechanical abnormalities and predisposition to injury. The use of biomechanical data, such as normative values for tibial rotation, is fundamental to prevention, and preventive exercise programs reduce the risk of rupture4. Defining these norms would help identify athletes at risk and personalize preventive strategies.

Instrumented assessment of laxity, using devices such as the DYNEELAX dynamic arthrometer, enables precise quantification of tibial rotation and anterior tibial translation under controlled loads. Its reliability has been proven5 and its use has been mastered at Toulon ("Unité de Médicine et Traumatologie du Sport") and Brest (Centre de Médecine du Sport"). It will be used in the PRELAX project to define normative tibial rotation values.

Detailed Description

This retrospective and prospective multicenter observational study aims to define normative values for overall (internal+external) knee rotational amplitudes in a population of healthy male and female athletes aged 15 and over, practising competitive pivot sports (between 2022 and 2026). Data will be collected in 2 centers: Toulon ("Unité de Médicine et Traumatologie du Sport") and Brest (Centre de Médecine du Sport").

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

1. Athletes with healthy knees, men and women ;
2. Age greater than or equal to 15 years;
3. Competitive pivot sports.

Exclusion Criteria

1. History of ligament, meniscus, cartilage or bone lesions in the knee ;
2. Pain, stiffness or instability in the knee at the time of inclusion;
3. Knee surgery, including ligament reconstruction;
4. Systemic diseases or medical conditions that may affect the musculoskeletal system;
5. Opposition of the participant and/or his/her legal representative in the case of a minor participant;
6. Participant under protective supervision.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measures of overall (internal+external) knee rotational amplitudes	day of medical examination (day 1)	Values of maximum knee rotational amplitudes (internal and external) measured by the DYNEELAX arthrometer: maximum internal and maximum external tibial rotation in degrees, taking into account the overall amplitude.

Secondary Outcome Measures

Name	Time	Method
Global rotation asymmetries between the two knees	day of medical examination (day 1)	Percentage of participants with significant asymmetry between left and right knees and level of asymmetry by calculating the mean and standard deviation of the asymmetry index
Correlation between rotational and translational laxity	day of medical examination (day 1)	Assessment of the strength and direction of the correlation between rotational and translational laxity with a Pearson correlation coefficient (varies between 0 and 1)

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer; 🇫🇷 Toulon, Var, France

Centre de Médecine du Sport; 🇫🇷 Brest, France