All studies
Enrolling by invitationNAINTERVENTIONAL

Long-term Follow up of the Stability 1 Trial

This study is a long-term check-up for people who had knee surgery between 2014 and 2017. These patients had a torn anterior cruciate ligament (ACL) and were at high risk of re-injuring their knee. Some had just the standard ACL reconstruction, while others also had an extra procedure called a lateral extra-articular tenodesis (LET). Previous results showed that adding the LET reduced the chance of the knee becoming unstable or needing another surgery for the same problem. Now, we want to understand the longer-term effects. There's a small concern that adding the LET might increase the risk of developing knee arthritis (osteoarthritis) later on. This study will use X-rays or scans and questionnaires to see if this is true 10 years after their surgery. We'll also look at their general knee health, how active they are, and any costs linked to their knee injury.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
Western University, Canada
Enrolment target
510
Start
01 Nov 2024
Estimated completion
01 Mar 2027

What is this study about?

This study is a follow-up for people who had knee surgery between 2014 and 2017. The surgery was to fix a torn ligament in their knee, called the anterior cruciate ligament (ACL). Some of these patients had an additional procedure during their surgery, known as a lateral extra-articular tenodesis (LET). We previously found that adding this LET procedure made the knee more stable and reduced the chance of the repaired ligament tearing again.

Because of these positive results, more doctors are now offering the LET procedure, and more patients are asking for it. However, it's really important to understand if there are any long-term downsides. There's a slight concern that the LET might increase the risk of developing joint wear and tear, known as osteoarthritis (OA), in the knee later in life. Knee osteoarthritis is a common condition that can cause pain and stiffness, and it's especially concerning if it affects younger people.

So, the main goal of this study is to see if adding the LET procedure really does increase the risk of developing knee osteoarthritis 10 years after the ACL surgery. We will check this using medical scans and by asking patients about their knee health and how it affects their daily lives. We will also gather information on their overall knee well-being, how active they are in sports, and any costs related to their knee injury or rehabilitation. Understanding these long-term effects is crucial so that doctors and patients can make the best choices together, not just for their immediate recovery but for the future health of their knee.

Key takeaways

  • This study aims to understand the long-term effects of a specific knee surgery often used for ACL tears.
  • It focuses on whether an additional procedure (LET) might increase the risk of knee arthritis 10 years later.
  • Information from this study will help doctors and patients make better choices for future knee surgeries.
  • Participants will provide information through questionnaires and possibly knee scans about their current knee health.

Who may be eligible?

This study is a long-term check-up for people who were part of the original Stability 1 trial. If you were in that study, you would have had surgery for a torn ACL ligament.

Generally, those eligible for the original study were young adults, usually between 14 and 25 years old. They had an ACL injury and were considered at high risk for re-injury. This might have been because they played competitive sports that involve twisting or pivoting, their knee showed a specific kind of instability (called a pivot shift), or they had generally flexible joints.

People were not included if they had previously had ACL surgery on either knee, had multiple knee ligaments needing surgery at the same time, had serious damage to the joint cartilage that needed more than just a tidy-up, had a specific alignment issue with their leg, or couldn't fill out health questionnaires.

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. Were you part of the original Stability 1 trial between 2014 and 2017?
  2. Did you have surgery for a torn ACL ligament during that time?
  3. Were you generally between 14 and 25 years old when you had the surgery?
  4. Were you considered at high risk for re-injury (e.g., played pivoting sports, had knee instability)?
Answer every question to see your result.

What does participation involve?

As this is a long-term follow-up study, your participation would involve providing information about your knee health 10 years after your original surgery. This will likely include completing questionnaires about your knee pain, function, and activities. You may also be asked to have imaging scans, like X-rays or MRI, of your operated knee to check for signs of arthritis. The study team will also review your medical records related to your knee injury and recovery. The specific details and number of visits will be explained by the study team, but it primarily focuses on gathering information at the 10-year mark.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers understand the long-term effects of different ACL reconstruction procedures. This knowledge will help future patients and doctors make more informed decisions about knee surgery, potentially leading to better long-term outcomes for others. As this is a follow-up study, it's unlikely to involve new medical treatments, so there are no known direct medical benefits to you. Potential risks are generally minimal, mostly relating to the time commitment for questionnaires and appointments for scans, and the potential discomfort of undergoing imaging procedures. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banff Sport Medicine Clinic
    Verified postcode
    Banff, Canada
  • University of Calgary
    Verified postcode
    Calgary, Canada
  • Fraser Health Authority
    Verified postcode
    New Westminster, Canada
  • Pan Am Clinic
    Verified postcode
    Winnipeg, Canada
  • McMaster University
    Verified postcode
    Hamilton, Canada
  • Queens University
    Verified postcode
    Kingston, Canada
  • Fowler Kennedy Sport Medicine Clinic
    Verified postcode
    London, Canada
  • University Hospitals Coventry and Warwickshire NHS Trust
    Verified postcode
    Coventry, United Kingdom

Common questions

What is an ACL and why is it important?

The ACL (anterior cruciate ligament) is a major ligament in your knee that helps keep it stable. If it's torn, your knee can feel unstable, especially during sports or sudden movements.

What is knee osteoarthritis (OA)?

Knee osteoarthritis is a common condition where the cartilage protecting your knee joint wears down. This can cause pain, stiffness, and swelling in the knee.

What is the difference between ACL reconstruction and LET?

ACL reconstruction is the main surgery to fix a torn ACL. An LET (lateral extra-articular tenodesis) is an additional, smaller procedure that can be done at the same time to further stabilise the knee, particularly for those at high risk of re-injury.

Will taking part in this study change my current treatment?

No, this study is a follow-up to understand long-term outcomes and will not involve any new treatments or changes to your current medical care. It's about gathering information.

Who is funding this study?

The study details don't mention the funders, but research like this is typically supported by grants from medical research organisations or government health bodies.

How to find out more

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 "Long-term Follow up of the Stability 1 Trial…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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