Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy (LAX)

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.

Study Overview

• Status: Recruiting
• Conditions: Women; Hormone; Tibial Translation
• Intervention / Treatment: Other: Questionnaire; Other: Beighton test; Other: Lachman Test

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre-Alexis GAUCI; Phone Number: +33 04 92 03 61 90; Email: gauci.pa@chu-nice.fr

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Recruiting
      • CHU Nice - Hopital de l'Archet 2
      • Contact: Pierre-Alexis GAUCI; Phone Number: +33 04 92 03 61 90; Email: gauci.pa@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Women on estrogen-progestin contraception; For women on estrogen-progestin contraception: Correct use of the estrogen-progestin pill in accordance with AMM Or wearing a vaginal ring according to AMM protocol Or wearing a contraceptive skin patch according to AMM protocol; Regular cycles of 26 to 33 days	Other: Questionnaire; Questionnaires on contraception and sports activities; Other: Beighton 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.; Other: Lachman 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.
Experimental: Group 2 Women on progestogen contraception; For women on progestin-only contraception: o Continuous use of the micro-progestogen or progestogen pill Or subcutaneous hormonal implant, Or a progesterone intrauterine device Or dienogest-type contraception	Other: Questionnaire; Questionnaires on contraception and sports activities; Other: Beighton 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.; Other: Lachman 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.
Experimental: Group 3 Women without hormonal contraception; For women without hormonal contraception : No method of contraception Or copper intrauterine device; Regular cycles of 26 to 33 days	Other: Questionnaire; Questionnaires on contraception and sports activities; Other: Beighton 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.; Other: Lachman 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: knee; anterior cruciate ligament; hormonale; anterior tibial translation
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 23-PP-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No