Active not recruitingNAINTERVENTIONAL

Fixed Versus Adjustable Loop in ACL Reconstruction

If you've torn your ACL (anterior cruciate ligament), often during sports, you might need surgery to fix it. This study is exploring two different ways surgeons can attach the new ligament (made from your hamstring tendons) in your thigh bone. One method uses a 'fixed loop' and the other an 'adjustable loop'. The aim is to see if one of these methods leads to better recovery and helps your knee feel more stable. We'll be enrolling 150 patients and following their progress for two years after surgery. We'll ask about how their knee feels and works, and do special tests to measure its stability. This research will help doctors understand which technique gives the best results for people having ACL reconstruction.

At a glance

Status

Active not recruiting

Phase

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrolment target

165

Start

05 Jul 2017

Estimated completion

31 Jan 2026

Anterior Cruciate Ligament Reconstruction

What is this study about?

Knee injuries, especially a torn Anterior Cruciate Ligament (ACL), are quite common, particularly if you play sports. The ACL is a really important ligament that helps keep your knee stable. When it tears, your knee can feel wobbly or 'give way', making it hard to get back to activities you enjoy. Many younger or active people choose to have surgery to rebuild the ACL.

During this surgery, doctors often use parts of your own hamstring tendons from the back of your knee to create a new ligament. This new ligament is then passed through tunnels drilled in your shin bone and thigh bone. While the new ligament is usually secured in your shin bone with a screw, there are different ways to attach it in your thigh bone. In Exeter, surgeons typically use a device called a 'suspensory loop'.

There are two main types of suspensory loops: 'fixed' and 'adjustable'. The amount of your new ligament that sits inside the bone tunnels is important for how well it heals and attaches. With a 'fixed loop', once it's in place, you can't change how much of the new ligament is sitting in the bone. However, an 'adjustable loop' allows the surgeon to make small changes during the operation, potentially ensuring the best possible amount of the new ligament is secured in the bone tunnels. This study aims to find out if one of these loop systems works better than the other, helping patients achieve a stronger, more stable knee.

Key takeaways

This study compares two ways of fixing a new ACL ligament during knee surgery.
It aims to find out if a 'fixed' or 'adjustable' loop system works better for attaching the new ligament.
Participants will be randomly assigned to one of the two methods.
Your recovery will be monitored for two years after surgery.
This research helps surgeons understand the best techniques for ACL reconstruction.
You must be 16-50 years old with an isolated ACL injury to participate.

Who may be eligible?

This study is looking for people aged 16 to 50 who need ACL reconstruction surgery. You can only take part if your ACL is the only ligament injured in your knee, or if you have a very small tear in your meniscus that needs fixing at the same time as your ACL.

You need to be willing to regularly attend follow-up appointments and physical checks after the surgery. The operation must also be performed at either The Royal Devon and Exeter Hospital or Sidmouth Hospital.

You won't be able to join the study if you've had previous knee surgery on that knee, have other serious knee injuries, or if there are signs of arthritis in your knee. We also can't include pregnant women or people with certain nerve or muscle conditions.

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.

Are you between 16 and 50 years old?
Is your ACL the only ligament in your knee that is significantly injured?
Are you having your surgery at The Royal Devon and Exeter Hospital or Sidmouth Hospital?
Are you willing and able to attend follow-up appointments for two years?
Have you *not* had previous knee surgery on the affected knee?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first sign a consent form. You will then be randomly assigned (like tossing a coin) to receive one of the two types of suspensory loops (fixed or adjustable) during your ACL reconstruction surgery. Apart from this specific part of the surgery, all other aspects of your care will be standard.

Over the next two years after your operation, you will have regular check-ups. These includes completing questionnaires about how your knee feels and functions. You'll also have special tests to measure your knee's stability at 3, 6, and 12 months after surgery. The total duration of your participation in terms of follow-up will be two years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a surgical technique that could potentially lead to a better outcome for your ACL reconstruction, though we are studying to find out which is best. All surgical procedures carry some risks, such as infection or bleeding, but these risks are not expected to be higher than usual for this type of surgery. There are no additional risks from being involved in the study itself. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom

Common questions

What is an ACL?

The ACL (Anterior Cruciate Ligament) is a key ligament in your knee that helps prevent your shin bone from sliding too far forward.

Why is the study comparing two types of loops?

The study wants to find out if one type of loop (fixed or adjustable) used to attach the new ligament in your thigh bone works better for patients' recovery.

Will I know which type of loop I get?

No, you will be randomly assigned to one of the two types, and your surgeon will decide during the operation. This helps make the study fair.

How long will I be involved in the study?

You'll be followed for two years after your surgery, with check-ups at 3, 6, and 12 months to see how you're recovering.

What if I change my mind about participating?

You can withdraw from the study at any time, and this will not affect the quality of your medical care.