Status:
RECRUITING
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Women
Tibial Translation
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 poor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06504953
Start Date
August 1 2024
End Date
August 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, France, 06200