WomenLAXNCT06504953
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
A study testing Questionnaire, Beighton test and Lachman Test in people with Women and Tibial Translation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Women are recognized as being at greater risk of ACL injury, with a risk 6 times higher than that of men. Hyperlaxity is a risk factor for ACL injury, but the pathophysiological basis for this is poorly studied. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women, Tibial Translation, Hormone
- What is being tested?
- Questionnaire, Beighton test and Lachman Test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between 18 and 40 years of age;
- No history of surgery on the 2 lower limbs;
- No change in contraceptive method in the last 6 months;
- Signature of informed consent ;
- Social security affiliation;
- D14 of her menstrual cycle (+/-1 day) (the first day of the cycle (D1) being considered as the first day of menstruation), except for those on unregulated micro-progestogen contraception.
Who cannot join
- Pregnancy or breastfeeding (check with urine pregnancy test);
- Menopause;
- Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy;
- History of inflammatory joint disease, systemic or localized to the knee;
- History of microcrystalline or infectious pathology localized to the knee;
- History of fracture, severe sprain or dislocation of the knee joint;
Show all 13Show fewer
- History of osteoarticular or congenital diseases that may lead to ACL laxity (e.g. Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome, etc.);
- Signs of hyperlaxity (Beighton test > 4);
- BMI > 25 ;
- Daily alcohol consumption above the thresholds recommended by Public Health in France (more than 2 glasses per day);
- Intense or unusual physical exercise during the last 72 hours before the inclusion visit;
- Inability to understand the protocol;
- Women under guardianship, curatorship or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Women are recognized as being at greater risk of ACL injury, with a risk 6 times higher than that of men. Hyperlaxity is a risk factor for ACL injury, but the pathophysiological basis for this is poorly studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for ACL injury. It therefore seems interesting to study the influence of hormonal impregnation on ligament laxity. To date, to our knowledge, no study has investigated such a relationship.
- Conditions
- Women, Tibial Translation, Hormone
- Being tested
- Questionnaire, Beighton test, Lachman Test
- Keywords
- hormonale, anterior tibial translation, knee, anterior cruciate ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires on contraception and sports activities
Beighton testOther
A popular screening technique for hypermobility. It consists of a nine-point scale requiring the performance of five maneuvers, four passive bilateral and one active unilateral.
Lachman TestOther
To perform this test, place your patient in a supine position and bring your patient's test leg to 30 degrees of flexion. Fix the femur with the other hand. Put the tibia in slight external rotation, then try to translate it forwards.
This test is positive if you feel a soft or limp end or if the anterior part.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Women on estrogen-progestin contraception | Experimental | For women on estrogen-progestin contraception:
* Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol
* Regular cycles of 26 to 33 days Receives: Other: Questionnaire; Other: Beighton test; Other: Lachman Test |
| Group 2 Women on progestogen contraception | Experimental | For women on progestin-only contraception:
o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception Receives: Other: Questionnaire; Other: Beighton test; Other: Lachman Test |
| Group 3 Women without hormonal contraception | Experimental | For women without hormonal contraception :
* No method of contraception Or copper intrauterine device
* Regular cycles of 26 to 33 days Receives: Other: Questionnaire; Other: Beighton test; Other: Lachman Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of anterior tibial translation of the knee with progestin-only hormonal contraception
To show that taking progestin-only hormonal contraception reduces anterior tibial translation of the knee compared with other types of contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee).
The degree of laxity is assessed using the international IKDC classification:
- Grade A 0 to 2 mm = normal
- Grade B 3 to 5 mm = almost normal
- Grade C 6 to 10 mm = abnormal
- Grade D > 10 mm = severely abnormal
Measured: 24 months
Secondary outcomes (7)
Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.
To show that taking progestin-only or estrogen-only contraception reduces anterior tibial translation of the knee compared with not taking hormonal contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee).
The degree of laxity is assessed using the international IKDC classification:
- Grade A 0 to 2 mm = normal
- Grade B 3 to 5 mm = almost normal
- Grade C 6 to 10 mm = abnormal
- Grade D > 10 mm = severely abnormal
Measured: 24 months
Anterior knee laxity at D14 and D25 of the cycle
Compare anterior tibial knee translation measured at D14 of the menstrual cycle with that measured at D25 of the menstrual cycle. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee).
The degree of laxity is assessed using the international IKDC classification:
- Grade A 0 to 2 mm = normal
- Grade B 3 to 5 mm = almost normal
- Grade C 6 to 10 mm = abnormal
- Grade D > 10 mm = severely abnormal
Measured: 14 or 25 days
Variable of height influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (height in meters) will be requested or measured during V1 of the study.
Measured: 24 months
Variable of weight influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (weight in kilograms) will be requested or measured during V1 of the study.
Measured: 24 months
Variable of age influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (age in years) will be requested or measured during V1 of the study.
Measured: 24 months
Variable of duration of contraceptive use influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (duration of contraceptive use in days) will be requested or measured during V1 of the study.
Measured: 24 months
Variable of cycle lenght influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (cycle length in days) will be requested or measured during V1 of the study.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Aug 2024
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504953
- Sponsor's protocol ID
- 23-PP-17
- Acronym
- LAX
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
- ClinicalTrials.gov ID
- NCT06504953
- Acronym / sponsor ID
- LAX / 23-PP-17
- Conditions
- Women, Tibial Translation, Hormone
- Keywords
- hormonale, anterior tibial translation, knee, anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 17 Jul 2024 (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.
Women are recognized as being at greater risk of ACL injury, with a risk 6 times higher than that of men. Hyperlaxity is a risk factor for ACL injury, but the pathophysiological basis for this is poorly studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for ACL injury. It therefore seems interesting to study the influence of hormonal impregnation on ligament laxity. To date, to our knowledge, no study has investigated such a relationship.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Women on estrogen-progestin contraception | Experimental | Other: Questionnaire, Other: Beighton test, Other: Lachman TestFor women on estrogen-progestin contraception: * Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol * Regular cycles of 26 to 33 days |
| Group 2 Women on progestogen contraception | Experimental | Other: Questionnaire, Other: Beighton test, Other: Lachman TestFor women on progestin-only contraception: o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception |
| Group 3 Women without hormonal contraception | Experimental | Other: Questionnaire, Other: Beighton test, Other: Lachman TestFor women without hormonal contraception : * No method of contraception Or copper intrauterine device * Regular cycles of 26 to 33 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female between 18 and 40 years of age;
- No history of surgery on the 2 lower limbs;
- No change in contraceptive method in the last 6 months;
- Signature of informed consent ;
- Social security affiliation;
Key exclusion criteria (13 listed)
- Pregnancy or breastfeeding (check with urine pregnancy test);
- Menopause;
- Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy;
- History of inflammatory joint disease, systemic or localized to the knee;
- History of microcrystalline or infectious pathology localized to the knee;
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 |
|---|---|---|
| QuestionnaireQuestionnaires on contraception and sports activities | Other | Group 1 Women on estrogen-progestin contraception, Group 2 Women on progestogen contraception, Group 3 Women without hormonal contraception |
| Beighton testA popular screening technique for hypermobility. It consists of a nine-point scale requiring the performance of five maneuvers, four passive bilateral and one active unilateral. | Other | Group 1 Women on estrogen-progestin contraception, Group 2 Women on progestogen contraception, Group 3 Women without hormonal contraception |
| Lachman TestTo perform this test, place your patient in a supine position and bring your patient's test leg to 30 degrees of flexion. Fix the femur with the other hand. Put the tibia in slight external rotation, then try to translate it forwards. This test is positive if you feel a soft or limp end or if the anterior part. | Other | Group 1 Women on estrogen-progestin contraception, Group 2 Women on progestogen contraception, Group 3 Women without hormonal contraception |
Primary outcome
Change of anterior tibial translation of the knee with progestin-only hormonal contraception
Time frame: 24 months
To show that taking progestin-only hormonal contraception reduces anterior tibial translation of the knee compared with other types of contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee). The degree of laxity is assessed using the international IKDC classification: * Grade A 0 to 2 mm = normal * Grade B 3 to 5 mm = almost normal * Grade C 6 to 10 mm = abnormal * Grade D > 10 mm = severely abnormal
7 secondary outcomes
Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.
Time frame: 24 months
Anterior knee laxity at D14 and D25 of the cycle
Time frame: 14 or 25 days
Variable of height influencing anterior tibial knee translation
Time frame: 24 months
Variable of weight influencing anterior tibial knee translation
Time frame: 24 months
Variable of age influencing anterior tibial knee translation
Time frame: 24 months
Variable of duration of contraceptive use influencing anterior tibial knee translation
Time frame: 24 months
Variable of cycle lenght influencing anterior tibial knee translation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, Beighton test and Lachman Test in people with Women and Tibial Translation, run by Centre Hospitalier Universitaire de Nice at 1 site 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of anterior tibial translation of the knee with progestin-only hormonal contraception (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.