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

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Hormone; Women; Tibial Translation

Treatments: Other: Lachman Test; Other: Questionnaire; Other: Beighton test

Study type: Interventional

Funder types: Other

Identifiers

NCT06504953

23-PP-17

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group 1 Women on estrogen-progestin contraception

Experimental group

Description:

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

Treatment:

Other: Beighton test

Other: Questionnaire

Other: Lachman Test

Group 2 Women on progestogen contraception

Experimental group

Description:

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

Treatment:

Other: Beighton test

Other: Questionnaire

Other: Lachman Test

Group 3 Women without hormonal contraception

Experimental group

Description:

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

Treatment:

Other: Beighton test

Other: Questionnaire

Other: Lachman Test