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Recruiting NCT06504953

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

No phase Interventional Women Tibial Translation Hormone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire, Beighton test, Lachman Test.
Who it may be relevant to
Registry conditions: Women, Tibial Translation, Hormone. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Questionnaire
    Questionnaires on contraception and sports activities
  • Other Beighton 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.
  • Other Lachman 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.

Primary outcome measures

  • Change of anterior tibial translation of the knee with progestin-only hormonal contraception [Time frame: 24 months]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Nice - Hôpital de l'Archet 2 — Nice

Identifiers

NCT: NCT06504953 · 23-PP-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗