Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 ;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Questionnaire
Other interventionQuestionnaires on contraception and sports activities
Beighton test
Other interventionA 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.
Lachman Test
Other interventionTo 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Group 1 Women on estrogen-progestin contraceptionExperimental treatment 3 interventions
Group B: Group 2 Women on progestogen contraceptionExperimental treatment 3 interventions
Group C: Group 3 Women without hormonal contraceptionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change of anterior tibial translation of the knee with progestin-only hormonal contraception
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
Time frame
24 monthsSecondary outcomes
1
Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.
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
Time frame
24 months2
Anterior knee laxity at D14 and D25 of the cycle
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
Time frame
14 or 25 days3
Variable of height influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (height in meters) will be requested or measured during V1 of the study.
Time frame
24 months4
Variable of weight influencing anterior tibial knee translation
Independent factors of ligament laxity in study women (weight in kilograms) will be requested or measured during V1 of the study.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov