Evaluation of Anterior Tibial Translation of the Knee in Healthy Women, at Two Times of the Menstrual Cycle, on Hormonal Contraceptives or Not (FLEX)

Women's participation in sports at all levels has been increasing in recent decades. Many individual and team sports are at risk of anterior cruciate ligament (ACL) injury. This injury leads to a permanent or long-lasting interruption of sports practice and to significant medical and economic expenses. Women are recognized as being more at risk of anterior cruciate ligament injury with a risk 6 times higher than men. Hyperlaxity is a risk factor for anterior cruciate ligament injury, but the pathophysiological bases are little studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for anterior cruciate ligament injury. It therefore seems interesting to investigators to study the influence of hormonal impregnation on ligament laxity. To date no study has investigated such a relationship.

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Key information

Conditions

Ligament; Laxity Joint Diseases Joint Instability Musculoskeletal Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06300, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Woman between 18 and 40 years old
No history of surgery of the 2 lower limbs
No change in contraceptive method in the last 6 months
Signature of the informed consent
Affiliation to the social security system
To be at Day 14 of her menstrual cycle (+/-1 day) (the first day of the cycle (Day1) being considered as the first day of the menstrual period), except for those on micro-progestative contraception not regulated

By inclusion group:

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

For women on estrogen-progestin contraception: Correct use of the estrogen-progestin pill according to the MA Or wearing a vaginal ring according to the MA protocol Or wearing a contraceptive skin patch according to the MA protocol Regular cycles of 26 to 33 days

For women on micro-progestin contraception : Continuous use of the micro-progestogen pill Or wearing a subcutaneous hormonal implant,

Exception: women on micro-progestin contraception who are not regulated:

They may have an irregular cycle or no cycle to be included
They can be included on any day if they have no cycle

Exclusion criteria

Pregnancy or breastfeeding in progress
Hormonal intrauterine device or injectable contraception
Menopause (defined as no menstruation for one year)
Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy
History of microcrystalline or infectious pathology localized to the knee
History of systemic or localized inflammatory joint disease of the knee
History of fracture, severe sprain or dislocation of the knee joint
History of osteoarticular or congenital diseases that may lead to laxity (Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome...)
Sign of hyperlaxity evaluated by a Beighton score higher than 4 (see appendix)
BMI > 25
Daily alcohol consumption above the thresholds recommended by Public Health in France (more than 2 glasses per day)
Woman unable to understand the protocol
Intense or unusual physical exercise during the last 72 hours (e.g.: marathon, triathlon, competitive cycling race...)
Woman under guardianship, curatorship or deprived of liberty

Treatment and study plan

Bilateral knee examination with Lachmeter®

Other

Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee

Primary outcomes

anterior tibial translation of the knee

Time frame: Day1 (inclusion visit)
The anterior tibial translation of the knee will be considered as representative of the anterior laxity of the knee of women under hormonal contraception via the Lachman test at 30° measured with a digital arthrometer type Lachmeter® (bilateral examination repeated 3 times on each knee).The degree of laxity will be evaluated thanks to the international classification IKDC:
- 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: FLEX

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 4, 2022
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed