Hormone, Tibial Translation, Women
Conditions
Keywords
hormonale, anterior tibial translation, knee, anterior cruciate ligament
Brief summary
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.
Interventions
OTHERQuestionnaire
Questionnaires on contraception and sports activities
OTHERBeighton test
A popular screening technique for hypermobility. It consists of a nine-point scale requiring the performance of five maneuvers, four passive bilateral and one active unilateral.
OTHERLachman Test
To perform this test, place your patient in a supine position and bring your patient's test leg to 30 degrees of flexion. Fix the femur with the other hand. Put the tibia in slight external rotation, then try to translate it forwards. This test is positive if you feel a soft or limp end or if the anterior part.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of anterior tibial translation of the knee with progestin-only hormonal contraception | 24 months | To show that taking progestin-only hormonal contraception reduces anterior tibial translation of the knee compared with other types of contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee). The degree of laxity is assessed using the international IKDC classification: * Grade A 0 to 2 mm = normal * Grade B 3 to 5 mm = almost normal * Grade C 6 to 10 mm = abnormal * Grade D \> 10 mm = severely abnormal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception. | 24 months | To show that taking progestin-only or estrogen-only contraception reduces anterior tibial translation of the knee compared with not taking hormonal contraception. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee). The degree of laxity is assessed using the international IKDC classification: * Grade A 0 to 2 mm = normal * Grade B 3 to 5 mm = almost normal * Grade C 6 to 10 mm = abnormal * Grade D \> 10 mm = severely abnormal |
| Anterior knee laxity at D14 and D25 of the cycle | 14 or 25 days | Compare anterior tibial knee translation measured at D14 of the menstrual cycle with that measured at D25 of the menstrual cycle. Anterior tibial knee translation will be considered representative of anterior knee laxity in women on hormonal contraception, using the 30° Lachman test measured with a Lachmeter® digital arthrometer (bilateral examination repeated 3 times on each knee). The degree of laxity is assessed using the international IKDC classification: * Grade A 0 to 2 mm = normal * Grade B 3 to 5 mm = almost normal * Grade C 6 to 10 mm = abnormal * Grade D \> 10 mm = severely abnormal |
| Variable of height influencing anterior tibial knee translation | 24 months | Independent factors of ligament laxity in study women (height in meters) will be requested or measured during V1 of the study. |
| Variable of weight influencing anterior tibial knee translation | 24 months | Independent factors of ligament laxity in study women (weight in kilograms) will be requested or measured during V1 of the study. |
| Variable of age influencing anterior tibial knee translation | 24 months | Independent factors of ligament laxity in study women (age in years) will be requested or measured during V1 of the study. |
| Variable of duration of contraceptive use influencing anterior tibial knee translation | 24 months | Independent factors of ligament laxity in study women (duration of contraceptive use in days) will be requested or measured during V1 of the study. |
| Variable of cycle lenght influencing anterior tibial knee translation | 24 months | Independent factors of ligament laxity in study women (cycle length in days) will be requested or measured during V1 of the study. |
Countries
France
Outcome results
None listed