Clinical trial NCT06504953: Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Official title: Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Women
Tibial Translation
Hormone
Keywords: hormonale
anterior tibial translation
knee
anterior cruciate ligament
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Change of anterior tibial translation of the knee with progestin-only hormonal contraception
timeFrame: 24 months
Secondary outcomes:
measure: Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.
timeFrame: 24 months
measure: Anterior knee laxity at D14 and D25 of the cycle
timeFrame: 14 or 25 days
measure: Variable of height influencing anterior tibial knee translation
timeFrame: 24 months
measure: Variable of weight influencing anterior tibial knee translation
timeFrame: 24 months
measure: Variable of age influencing anterior tibial knee translation
timeFrame: 24 months
measure: Variable of duration of contraceptive use influencing anterior tibial knee translation
timeFrame: 24 months
measure: Variable of cycle lenght influencing anterior tibial knee translation
timeFrame: 24 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital de l'Archet 2
state: Alpes-Maritimes
Study officials:
References: