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

May 22, 2026 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06300
        • Chu de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: on estrogen-progestin contraception
Other: Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
Experimental: under micro-progestational contraception
Other: Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee
Experimental: without hormonal contraception
Other: Bilateral knee examination with Lachmeter®
Bilateral knee examination with Lachmeter®. Examination repeated 3 times on each knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day1 (inclusion visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Christian ROUX, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2022

Primary Completion (Actual)

August 4, 2023

Study Completion (Actual)

August 4, 2023

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-AOI-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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