An observational study in Knee Ligament Injury, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Recruiting at 2 sites in France. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
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.
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").
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 482 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 77 studies on the registry; 20 are open to participants now.
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Healthy male and female athletes aged 15 and over practising competitive pivot sports and consulted at Toulon ("Unité de Médicine et Traumatologie du Sport") and Brest (Centre de Médecine du Sport") as part of their sports medicine follow-up
Exclusion Criteria:
Other: Measures of overall (internal+external) knee rotational amplitudes
Measures of overall (internal+external) knee rotational amplitudes by Dyneelax
Measures of overall (internal+external) knee rotational amplitudes
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.
Time frame: day of medical examination (day 1)
Global rotation asymmetries between the two knees
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
Time frame: day of medical examination (day 1)
Correlation between rotational and translational laxity
Assessment of the strength and direction of the correlation between rotational and translational laxity with a Pearson correlation coefficient (varies between 0 and 1)
Time frame: day of medical examination (day 1)
Plan to share: No
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer