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

NCT06504953 | Recruiting

• 1 other identifier: 23-PP-17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Women; Tibial Translation; Hormone

Keywords

hormonale; anterior tibial translation; knee; anterior cruciate ligament

Outcome Measures

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

  24 months

Secondary Outcomes (7)

• Change of anterior tibial translation of the knee with progestin-only hormonal contraception or estrogen-only contraception.

  24 months

• Anterior knee laxity at D14 and D25 of the cycle

  14 or 25 days

• Variable of height influencing anterior tibial knee translation

  24 months

• Variable of weight influencing anterior tibial knee translation

  24 months

• Variable of age influencing anterior tibial knee translation

  24 months

Study Arms (3)

Group 1 Women on estrogen-progestin contraception

EXPERIMENTAL

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; Other: Beighton test; Other: Lachman Test

Group 2 Women on progestogen contraception

EXPERIMENTAL

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; Other: Beighton test; Other: Lachman Test

Group 3 Women without hormonal contraception

EXPERIMENTAL

For women without hormonal contraception : * No method of contraception Or copper intrauterine device * Regular cycles of 26 to 33 days

Other: Questionnaire; Other: Beighton test; Other: Lachman Test

Interventions

Questionnaire OTHER

Questionnaires on contraception and sports activities

Group 1 Women on estrogen-progestin contraception; Group 2 Women on progestogen contraception; Group 3 Women without hormonal contraception

Beighton test OTHER

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.

Group 1 Women on estrogen-progestin contraception; Group 2 Women on progestogen contraception; Group 3 Women without hormonal contraception

Lachman Test OTHER

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.

Group 1 Women on estrogen-progestin contraception; Group 2 Women on progestogen contraception; Group 3 Women without hormonal contraception

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Inability to understand the protocol;
• Women under guardianship, curatorship or deprived of liberty.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, 06200, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pierre-Alexis GAUCI

CONTACT

04 92 03 61 90; gauci.pa@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

FR (1)