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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- At day 14 of menstrual cycle (+/-1 day), except for those on unregulated micro-progestogen contraception
You will not qualify if you...
- Pregnancy or breastfeeding (confirmed by urine pregnancy test)
- Menopause
- History of tubal ligation, oophorectomy, adnexectomy, or hysterectomy
- History of inflammatory joint disease, systemic or localized to the knee
- History of microcrystalline or infectious knee pathology
- History of fracture, severe sprain, or dislocation of the knee joint
- History of osteoarticular or congenital diseases causing ACL laxity (e.g., Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome)
- Signs of hyperlaxity (Beighton test > 4)
- BMI greater than 25
- Daily alcohol consumption above 2 glasses per day
- Intense or unusual physical exercise during the last 72 hours before inclusion
- Inability to understand the protocol
- Women under guardianship, curatorship, or deprived of liberty
AI-Screening
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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
CONTACT
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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