Knee Ligament InjuryPRELAXNCT07013019
Reference Values for Knee Rotational Amplitudes in a Population of Athletes
An observational study of Knee Ligament Injury, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Ligament Injury
- What is being tested?
- Measures of overall (internal+external) knee rotational amplitudes
- How many people
- 482 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jun 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Athletes with healthy knees, men and women ;
- Age greater than or equal to 15 years;
- Competitive pivot sports.
Who cannot join
- History of ligament, meniscus, cartilage or bone lesions in the knee ;
- Pain, stiffness or instability in the knee at the time of inclusion;
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre de Médecine du Sport
Brest
Christophe GUEGAN, MD
Christophe GUEGAN, MD
- Recruiting
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100
Jean-Jacques Raymond, MD
Jean-Jacques Raymond, MD
About this study
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.
Read more
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.
Read the 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
- Knee Ligament Injury
- Being tested
- Measures of overall (internal+external) knee rotational amplitudes
- Keywords
- Anterior cruciate ligament, Injury, Laxity, Pivot sport, Dynamic arthrometer
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of overall (internal+external) knee rotational amplitudesOther
Measures of overall (internal+external) knee rotational amplitudes by Dyneelax
| Study group | Role | What they receive |
|---|---|---|
| Healthy male and female athletes aged 15 and over practising competitive pivot sports | Not described Receives: Other: Measures of overall (internal+external) knee rotational amplitudes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day of medical examination (day 1)
Secondary outcomes (2)
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
Measured: 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)
Measured: day of medical examination (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start6 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Raymond, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur MerChristophe GUEGAN, MD, Principal investigator, Centre de Médecine du Sport de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013019
- Sponsor's protocol ID
- 2025-CHITS-008
- Acronym
- PRELAX
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16210574Andersen 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.
PubMed 9335025Mouton 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.
PubMed 26318487Arundale 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.
PubMed 36587265
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Knee Rotational Amplitudes in a Population of Athletes
- ClinicalTrials.gov ID
- NCT07013019
- Acronym / sponsor ID
- PRELAX / 2025-CHITS-008
- Conditions
- Knee Ligament Injury
- Keywords
- Anterior cruciate ligament, Injury, Laxity, Pivot sport, Dynamic arthrometer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male and female athletes aged 15 and over practising competitive pivot sports | – | Other: Measures of overall (internal+external) knee rotational amplitudes |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Athletes with healthy knees, men and women ;
- Age greater than or equal to 15 years;
- Competitive pivot sports.
Key exclusion criteria (6 listed)
- History of ligament, meniscus, cartilage or bone lesions in the knee ;
- Pain, stiffness or instability in the knee at the time of inclusion;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures of overall (internal+external) knee rotational amplitudesMeasures of overall (internal+external) knee rotational amplitudes by Dyneelax | Other | Healthy male and female athletes aged 15 and over practising competitive pivot sports |
Primary outcome
Measures of overall (internal+external) knee rotational amplitudes
Time frame: day of medical examination (day 1)
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.
2 secondary outcomes
Global rotation asymmetries between the two knees
Time frame: day of medical examination (day 1)
Correlation between rotational and translational laxity
Time frame: day of medical examination (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 16210574Ahmad 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.
- Background: PubMed 9335025Andersen 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.
- Background: PubMed 26318487Mouton 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.
- Background: PubMed 36587265Arundale 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.
- 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.2023.100254Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Jacques Raymond, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Christophe GUEGAN, MD principal investigator
Centre de Médecine du Sport de Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Ligament Injury, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Lafond (04 83 77 20 62 ext. +33, sophie.lafond@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of overall (internal+external) knee rotational amplitudes (time frame: day of medical examination (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013019, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.