Evaluation of Anterior Tibial Translation of the Knee in Healthy Women, at Two Times of the Menstrual Cycle, on Hormonal Contraceptives or Not (FLEX)
NCT ID: NCT05177549
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-06-08
2025-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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on estrogen-progestin contraception
Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
under micro-progestational contraception
Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
without hormonal contraception
Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
Interventions
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Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
Eligibility Criteria
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Inclusion Criteria
* No history of surgery of the 2 lower limbs
* No change in contraceptive method in the last 6 months
* Signature of the informed consent
* Affiliation to the social security system
* To be at Day 14 of her menstrual cycle (+/-1 day) (the first day of the cycle (Day1) being considered as the first day of the menstrual period), except for those on micro-progestative contraception not regulated
By inclusion group:
\- For women without hormonal contraception: No method of contraception Or a copper intrauterine device Regular cycles of 26 to 33 days
\- For women on estrogen-progestin contraception: Correct use of the estrogen-progestin pill according to the MA Or wearing a vaginal ring according to the MA protocol Or wearing a contraceptive skin patch according to the MA protocol Regular cycles of 26 to 33 days
\- For women on micro-progestin contraception : Continuous use of the micro-progestogen pill Or wearing a subcutaneous hormonal implant,
Exception: women on micro-progestin contraception who are not regulated:
* They may have an irregular cycle or no cycle to be included
* They can be included on any day if they have no cycle
Exclusion Criteria
* Hormonal intrauterine device or injectable contraception
* Menopause (defined as no menstruation for one year)
* Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy
* History of microcrystalline or infectious pathology localized to the knee
* History of systemic or localized inflammatory joint disease of the knee
* History of fracture, severe sprain or dislocation of the knee joint
* History of osteoarticular or congenital diseases that may lead to laxity (Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome...)
* Sign of hyperlaxity evaluated by a Beighton score higher than 4 (see appendix)
* BMI \> 25
* Daily alcohol consumption above the thresholds recommended by Public Health in France (more than 2 glasses per day)
* Woman unable to understand the protocol
* Intense or unusual physical exercise during the last 72 hours (e.g.: marathon, triathlon, competitive cycling race...)
* Woman under guardianship, curatorship or deprived of liberty
18 Years
40 Years
FEMALE
Yes
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Christian ROUX
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Locations
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CHU de Nice
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-AOI-01
Identifier Type: -
Identifier Source: org_study_id
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