Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy
NCT Number: NCT06504953
Acronym: LAX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women|Tibial Translation|Hormone
Interventions: OTHER: Questionnaire|OTHER: Beighton test|OTHER: Lachman Test
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-08
Locations: CHU Nice - Hôpital de l'Archet 2, Nice, Alpes-Maritimes, 06200, France

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.

Primary Outcome Measures: 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, 24 months
Secondary Outcome Measures: 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, 24 months|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, 14 or 25 days|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., 24 months|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., 24 months|Variable of age influencing anterior tibial knee translation, Independent factors of ligament laxity in study women (age in years) will be requested or measured during V1 of the study., 24 months|Variable of duration of contraceptive use influencing anterior tibial knee translation, Independent factors of ligament laxity in study women (duration of contraceptive use in days) will be requested or measured during V1 of the study., 24 months|Variable of cycle lenght influencing anterior tibial knee translation, Independent factors of ligament laxity in study women (cycle length in days) will be requested or measured during V1 of the study., 24 months