RecruitingNot ApplicableNCT06504953

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


Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

90 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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 Criteria13

  • 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.

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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.


Locations(1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, France

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NCT06504953


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