Reference Values for Knee Rotational Amplitudes in a Population of Athletes

NCT ID: NCT07013019

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

482 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-06

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Knee Ligament Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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

Measures of overall (internal+external) knee rotational amplitudes

Intervention Type OTHER

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

Interventions

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Measures of overall (internal+external) knee rotational amplitudes

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Jacques Raymond, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Christophe GUEGAN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Médecine du Sport de Brest

Locations

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Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, France

Site Status RECRUITING

Centre de Médecine du Sport

Brest, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Sophie Lafond

Role: CONTACT

04 83 77 20 62 ext. +33

Facility Contacts

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Jean-Jacques Raymond, MD

Role: primary

Christophe GUEGAN, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16210574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9335025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26318487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36587265 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.medntd.2023.100254

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

Other Identifiers

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2025-CHITS-008

Identifier Type: -

Identifier Source: org_study_id

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