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

NCT05177549 | Unknown

• 1 other identifier: 19-AOI-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ligament; Laxity

Keywords

hormonal impregnation

Outcome Measures

Primary Outcomes (1)

• anterior tibial translation of the knee

  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)

Study Arms (3)

on estrogen-progestin contraception

EXPERIMENTAL

Other: Bilateral knee examination with Lachmeter®

under micro-progestational contraception

EXPERIMENTAL

Other: Bilateral knee examination with Lachmeter®

without hormonal contraception

EXPERIMENTAL

Other: Bilateral knee examination with Lachmeter®

Interventions

Bilateral knee examination with Lachmeter® OTHER

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

on estrogen-progestin contraception; under micro-progestational contraception; without hormonal contraception

Eligibility Criteria

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

You may qualify if:

• 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
• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06300, France

RECRUITING

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Christian ROUX

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian ROUX

CONTACT

04 92 03 92 20; roux.c2@chu-nice.fr

Jerome DELOTTE

CONTACT

04 92 03 61 08; delotte.j@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: November 16, 2021
• First Posted: January 4, 2022
• Study Start: June 8, 2022
• Primary Completion: June 8, 2024
• Study Completion: February 15, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

FR (1)