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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how hormone therapy affects the stability of the knee in healthy women. Researchers want to understand why women are at a higher risk for ACL injuries, which are injuries to a key ligament in the knee. They believe that hormonal changes during a woman's menstrual cycle might play a role in this increased risk. The study aims to see if women taking hormone therapy have different knee stability compared to those who are not.

To participate in this study, women must be between 18 and 40 years old and should not have had any surgeries on their lower limbs in the past. They should also be in a specific phase of their menstrual cycle (around day 14) and not be pregnant or breastfeeding. Participants will undergo tests to assess their knee stability and will be closely monitored throughout the study. It's important for potential participants to understand the eligibility criteria and be aware that they will need to sign an informed consent form before joining the study.

Gender

FEMALE

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.