Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Recruiting now · Not applicable
Conditions studied: Women, Tibial Translation, Hormone
In brief
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.
Key facts
- Study ID
- NCT06504953
- Run by
- Centre Hospitalier Universitaire de Nice
- People needed
- 90
- Starts
- 2024-08-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-10-02
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- CHU Nice - Hôpital de l'Archet 2 — Nice, Alpes-Maritimes, France (enrolling)
Full record on ClinicalTrials.gov
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