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RecruitingNAINTERVENTIONAL

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

This research is investigating why women are more likely to injure a certain ligament in the knee, called the ACL, compared to men. One possible reason is that women's joints can be more flexible due to hormones. We're specifically looking at how different hormone levels might affect how loose or stable the knee joint is. Understanding this could help us find ways to prevent these injuries in the future. The study involves healthy women and uses simple tests, like a questionnaire and physical checks, to measure joint flexibility and gather information about their hormones. This is a new area of research, as no one has thoroughly explored this link before.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Universitaire de Nice
Enrolment target
90
Start
01 Aug 2024
Estimated completion
01 Aug 2026

What is this study about?

This study is all about understanding why women are more likely to experience a specific type of knee injury, called an ACL injury, compared to men. The ACL (Anterior Cruciate Ligament) is an important ligament that helps keep your knee stable. We know that women are six times more likely to injure their ACL, and one idea is that hormones might play a part in this.

Researchers think that different hormone levels, particularly during certain times of a woman's menstrual cycle, could make joints, including the knee, more flexible or 'loose'. While some flexibility is good, too much could make the knee less stable and more prone to injury. This study aims to explore this connection by looking at how various hormone levels might influence the stability of the knee joint.

The main goal is to see if there's a clear link between a woman's hormones and how much her knee joint moves. By understanding this better, doctors and researchers might be able to develop new strategies to help prevent ACL injuries in women. It's a new area of study, and the findings could be very important for women's health.

Key takeaways

  • Study explores why women are at higher risk for ACL knee injuries.
  • Focuses on how hormones might influence knee joint looseness.
  • Involves simple physical tests and a questionnaire.
  • Participation requires a single visit.
  • Helps advance understanding of women's knee health.

Who may be eligible?

To join this study, you need to be a woman between 18 and 40 years old. You must not have had any previous surgery on your legs, and if you use contraception, you shouldn't have changed your method in the last six months. You also need to be able to understand the study information and be willing to sign a consent form, and be covered by social security in France. For most participants, you'd need to be on day 14 of your menstrual cycle (day 1 is the first day of your period), unless you're on a specific type of birth control.

There are several reasons why you might not be able to join. These include being pregnant or breastfeeding, having reached menopause, or having had certain surgeries like a hysterectomy. You also wouldn't be eligible if you have a history of certain joint conditions, previous severe knee injuries or fractures, or conditions that affect joint looseness like Marfan syndrome.

Additionally, you can't join if you show signs of being overly flexible (checked by a simple test), have a BMI over 25, drink more alcohol than recommended, have done intense exercise in the last 72 hours, or if you can't understand the study rules. The study also cannot include women under legal guardianship or who are deprived of their freedom.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman between 18 and 40 years old?
  2. Have you had no leg surgery before?
  3. Have you kept the same birth control method for the last 6 months (if applicable)?
  4. Are you able to understand the study details and sign a consent form?
  5. Are you currently not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your contribution will involve a single visit. During this visit, you'll be asked to fill out a questionnaire about your health history and lifestyle. The research team will then perform two simple physical tests on your knee: the Beighton test, which checks for general joint flexibility, and the Lachman Test, which specifically assesses the stability of your knee. There are no medications involved and no follow-up visits planned for this study. The total duration of your participation will be the time it takes for this one visit and the assessments.

Potential risks and benefits

Potential benefits of participating are that you will contribute to important research aimed at understanding and preventing knee injuries in women, which could help many others in the future. You will also receive a mini health check-up on your knees with the physical tests. Potential risks are very low; the physical tests are generally safe and non-invasive, but you might feel slight discomfort during the knee assessments. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your routine medical care.

Locations (1)

  • CHU Nice - Hôpital de l'Archet 2
    Verified postcode
    Nice, France· Recruiting

Common questions

What is an ACL injury?

An ACL injury is when a key ligament in your knee, called the Anterior Cruciate Ligament, gets stretched or torn. It's a common sports injury and can make your knee unstable.

What does 'hormonal impregnation' mean?

In this study, it refers to the natural levels and effects of female hormones in your body, especially how they change during your menstrual cycle.

What is the Beighton test?

The Beighton test is a simple set of movements to check how flexible your joints are overall. It helps identify if someone has very loose joints.

What is the Lachman Test?

The Lachman Test is a specific physical examination that doctors use to check the stability of your ACL in the knee.

Will I receive any treatment in this study?

No, this study is observational, meaning we are just collecting information and performing assessments. It does not involve any treatment or medication.

How to find out more

Pierre-Alexis GAUCI

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of Anterior Tibial Knee Translation in Healthy Wo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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