Clinical trial NCT07013019: Reference Values for Knee Rotational Amplitudes in a Population of Athletes
Official title: Reference Values for Knee Rotational Amplitudes in a Population of Athletes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Ligament Injury
Keywords: Anterior cruciate ligament
Injury
Laxity
Pivot sport
Dynamic arthrometer
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 482
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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").

Eligibility criteria: 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.

Primary outcomes:
measure: Measures of overall (internal+external) knee rotational amplitudes
timeFrame: day of medical examination (day 1)
Secondary outcomes:
measure: Global rotation asymmetries between the two knees
timeFrame: day of medical examination (day 1)
measure: Correlation between rotational and translational laxity
timeFrame: day of medical examination (day 1)
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
city: Brest
country: France
facility: Centre de Médecine du Sport
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jean-Jacques Raymond, MD
role: STUDY_DIRECTOR
affiliation: Centre de Médecine du Sport de Brest
name: Christophe GUEGAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad CS, Clark AM, Heilmann N, Schoeb JS, Gardner TR, Levine WN. Effect of gender and maturity on quadriceps-to-hamstring strength ratio and anterior cruciate ligament laxity. Am J Sports Med. 2006 Mar;34(3):370-4. doi: 10.1177/0363546505280426. Epub 2005 Oct 6.
citation: Andersen HN, Dyhre-Poulsen P. The anterior cruciate ligament does play a role in controlling axial rotation in the knee. Knee Surg Sports Traumatol Arthrosc. 1997;5(3):145-9. doi: 10.1007/s001670050042.
citation: Mouton C, Theisen D, Meyer T, Agostinis H, Nuhrenborger C, Pape D, Seil R. Combined anterior and rotational knee laxity measurements improve the diagnosis of anterior cruciate ligament injuries. Knee Surg Sports Traumatol Arthrosc. 2015 Oct;23(10):2859-67. doi: 10.1007/s00167-015-3757-7. Epub 2015 Aug 30.
citation: Arundale AJH, Bizzini M, Dix C, Giordano A, Kelly R, Logerstedt DS, Mandelbaum B, Scalzitti DA, Silvers-Granelli H, Snyder-Mackler L. Exercise-Based Knee and Anterior Cruciate Ligament Injury Prevention. J Orthop Sports Phys Ther. 2023 Jan;53(1):CPG1-CPG34. doi: 10.2519/jospt.2023.0301.