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CompletedNCT06504953LAXUpdated Sep 10, 2026

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

An interventional study of Questionnaire and Beighton test in Women, Tibial Translation and Hormone, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Women
  • Tibial Translation
  • Hormone

Keywords

  • hormonale
  • anterior tibial translation
  • knee
  • anterior cruciate ligament
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Group 1 Women on estrogen-progestin contraception

    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

    Other: Questionnaire · Other: Beighton test · Other: Lachman Test

  • Experimental
    Group 2 Women on progestogen contraception

    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

    Other: Questionnaire · Other: Beighton test · Other: Lachman Test

  • Experimental
    Group 3 Women without hormonal contraception

    For women without hormonal contraception : * No method of contraception Or copper intrauterine device * Regular cycles of 26 to 33 days

    Other: Questionnaire · Other: Beighton test · Other: Lachman Test

Interventions

  • OtherQuestionnaire

    Questionnaires on contraception and sports activities

  • OtherBeighton test

    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.

  • OtherLachman Test

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 24 months

  2. 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

    Time frame: 14 or 25 days

  3. 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.

    Time frame: 24 months

  4. 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.

    Time frame: 24 months

  5. 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.

    Time frame: 24 months

  6. 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.

    Time frame: 24 months

  7. 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.

    Time frame: 24 months

07

Study locations

1 site
  • CHU Nice - Hôpital de l'Archet 2
    Nice, Alpes-Maritimes 06200, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06504953
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Aug 1, 2024
Primary completion
Jun 17, 2026
Completion
Jun 17, 2026
Last update
Sep 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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