Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06504953

Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Women Hormone Tibial Translation

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, 06200, France

Location status: Recruiting

Location contact

Pierre-Alexis GAUCI

CONTACT

[email protected]

04 92 03 61 90 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Questionnaire

Other

Questionnaires on contraception and sports activities

Beighton test

Other

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 Test

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.

    Time frame: 24 months

    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

  2. Anterior knee laxity at D14 and D25 of the cycle

    Time frame: 14 or 25 days

    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

  3. Variable of height influencing anterior tibial knee translation

    Time frame: 24 months

    Independent factors of ligament laxity in study women (height in meters) will be requested or measured during V1 of the study.

  4. Variable of weight influencing anterior tibial knee translation

    Time frame: 24 months

    Independent factors of ligament laxity in study women (weight in kilograms) will be requested or measured during V1 of the study.

  5. Variable of age influencing anterior tibial knee translation

    Time frame: 24 months

    Independent factors of ligament laxity in study women (age in years) will be requested or measured during V1 of the study.

  6. Variable of duration of contraceptive use influencing anterior tibial knee translation

    Time frame: 24 months

    Independent factors of ligament laxity in study women (duration of contraceptive use in days) will be requested or measured during V1 of the study.

  7. Variable of cycle lenght influencing anterior tibial knee translation

    Time frame: 24 months

    Independent factors of ligament laxity in study women (cycle length in days) will be requested or measured during V1 of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Alexis GAUCI

CONTACT

[email protected]

04 92 03 61 90 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: LAX

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.