Evaluating knee translation in women with and without hormone therapy
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
This study is testing how hormone therapy affects knee stability in healthy women aged 18 to 40 to see if it influences the risk of ACL injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-Maritimes) |
| Trial ID | NCT06504953 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between hormonal therapy and anterior tibial translation in healthy women. It aims to understand how hormonal factors and menstrual cycle phases may influence ligament laxity, particularly in relation to the risk of anterior cruciate ligament (ACL) injuries. Participants will undergo assessments including questionnaires, the Beighton test, and the Lachman test to evaluate their knee stability. The study focuses on women aged 18 to 40 who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18 to 40 with no history of lower limb surgery or significant knee issues.
Not a fit: Patients who are pregnant, breastfeeding, or have undergone menopause will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the hormonal influences on ACL injury risk, potentially leading to better prevention strategies for women.
How similar studies have performed: While the specific relationship between hormonal therapy and ACL injury risk has not been extensively studied, similar investigations into hormonal influences on ligament laxity have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nice, Alpes-Maritimes
- CHU Nice - Hôpital de l'Archet 2 — Nice, Alpes-Maritimes, France (Recruiting)
Study contacts
- Study coordinator: Pierre-Alexis GAUCI
- Email: gauci.pa@chu-nice.fr
- Phone: 04 92 03 61 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.