Reference Values for Knee Rotational Amplitudes in a Population of Athletes

NCT07013019 | Recruiting

• 1 other identifier: 2025-CHITS-008
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Ligament Injury

Keywords

Anterior cruciate ligament; Injury; Laxity; Pivot sport; Dynamic arthrometer

Outcome Measures

Primary Outcomes (1)

• 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.

  day of medical examination (day 1)

Secondary Outcomes (2)

• Global rotation asymmetries between the two knees

  day of medical examination (day 1)

• Correlation between rotational and translational laxity

  day of medical examination (day 1)

Study Arms (1)

Healthy male and female athletes aged 15 and over practising competitive pivot sports

Other: Measures of overall (internal+external) knee rotational amplitudes

Interventions

Measures of overall (internal+external) knee rotational amplitudes OTHER

Measures of overall (internal+external) knee rotational amplitudes by Dyneelax

Healthy male and female athletes aged 15 and over practising competitive pivot sports

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• History of ligament, meniscus, cartilage or bone lesions in the knee ;
• Knee surgery, including ligament reconstruction;
• Systemic diseases or medical conditions that may affect the musculoskeletal system;
• Opposition of the participant and/or his/her legal representative in the case of a minor participant;
• Participant under protective supervision.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (2)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

RECRUITING

Centre de Médecine du Sport

Brest, France

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 16210574 BACKGROUND

• 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.

  PMID: 9335025 BACKGROUND

• 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.

  PMID: 26318487 BACKGROUND

• 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.

  PMID: 36587265 BACKGROUND

Related Links

• Cojean T, Batailler C, Robert H, Cheze L. Sensitivity, repeatability and reproducibility study with a leg prototype of a recently developed knee arthrometer: The DYNEELAX®. Med Nov Technol Devices. 2023 Sep 1. doi: 10.1016/j.medntd.2023.100254

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jean-Jacques Raymond, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

• Christophe GUEGAN, MD

  Centre de Médecine du Sport de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Lafond

CONTACT

04 83 77 20 62; sophie.lafond@ch-toulon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 10, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)