Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07013019

Reference Values for Knee Rotational Amplitudes in a Population of Athletes

Status
Recruiting
Phase
Study type
Observational
Enrollment
482 (estimated)
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Accepted

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").

Conditions

Interventions

TypeNameDescription
OTHERMeasures of overall (internal+external) knee rotational amplitudesMeasures of overall (internal+external) knee rotational amplitudes by Dyneelax

Timeline

Start date
2025-06-06
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2025-06-10
Last updated
2026-04-14

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT07013019. Inclusion in this directory is not an endorsement.