Actively Recruiting
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-10-02
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Women have a higher risk of anterior cruciate ligament (ACL) injury compared to men, with several factors such as ligament looseness and hormonal changes during menstrual cycles potentially influencing this risk. Researchers are studying how hormone therapy, particularly the effects of estrogen and progestin contraception, might affect knee ligament laxity in healthy women. This study aims to better understand the relationship between hormonal impregnation and ligament looseness, which has not been previously explored in detail. Participants will be divided into three groups based on their hormonal contraception use: women using estrogen-progestin contraception, women using progestin-only contraception, and women not using hormonal contraception. Each group follows specific contraceptive protocols or has regular menstrual cycles. The study involves tests like the Beighton test for hypermobility and the Lachman test to measure knee ligament looseness. Questionnaires about contraception use and sports activities are also part of the study. Women aged 18 to 40 can participate and will be assessed at specific points in their menstrual cycle or contraception use. Researchers will measure changes in anterior tibial knee translation over 24 months, along with factors like height, weight, age, contraceptive duration, and cycle length. Safety and eligibility are monitored through criteria such as pregnancy status, medical history, and lifestyle factors. The study includes informed consent and social security affiliation requirements to ensure participant safety and compliance.
CONDITIONS
Brief Title
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- On day 14 (+/-1 day) of menstrual cycle, except for those on unregulated micro-progestogen contraception
You will not qualify if you...
- Pregnancy or breastfeeding
- Menopause
- Surgery such as tubal ligation, oophorectomy, adnexectomy, or 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)
- Signs of hyperlaxity (Beighton test > 4)
- Body mass index over 25
- Daily alcohol consumption above recommended thresholds in France (more than 2 glasses per day)
- Intense or unusual physical exercise during the last 72 hours before inclusion visit
- Inability to understand the protocol
- Women under guardianship, curatorship or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo assessments including questionnaires and physical tests to evaluate knee translation related to hormonal contraception use.
Visits at Day 14 and Day 25 of menstrual cycle and additional visits over 24 months
Trial Site Locations
Total: 1 location
1
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, France, 06200
Actively Recruiting
Research Team
P
Pierre-Alexis GAUCI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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