Active not recruitingNAINTERVENTIONAL

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

This study, called STABILITY 2, explores the best surgical options for young, active people who have torn a key knee ligament, the Anterior Cruciate Ligament (ACL). When this ligament is torn, it can cause problems with knee stability. About 30% of young people under 20 who have this surgery re-injure their knee. This can lead to more operations and long-term joint pain. Researchers are comparing different materials used for the new ligament and whether adding an extra procedure, called Lateral Tenodesis, can make the knee more stable. The aim is to find out which surgical approach works best to prevent re-injury and improve knee health over time.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Pittsburgh

Enrolment target

1,236

Start

28 Jul 2020

Estimated completion

30 Jun 2028

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Reconstruction Joint Instability

What is this study about?

When you tear a ligament in your knee, especially the Anterior Cruciate Ligament (ACL), it can cause your knee to feel unstable. This is a common injury, especially in young people who play sports. Often, surgery is needed to fix it. However, even after surgery, many young people experience problems, including re-injuring the knee again. This can lead to more surgery, ongoing pain, and a higher chance of developing arthritis in the knee later in life. That's why it's really important to find the best ways to make these surgeries as successful as possible.

There are different ways surgeons can fix an ACL. They often use a piece of tissue (called a graft) from another part of your own body to replace the torn ligament. Common choices are tissue from your kneecap area or your quadriceps muscle. Doctors also wonder if adding an extra procedure, called a Lateral Extra-articular Tenodesis (LET), could make the knee even more stable and prevent re-injury. However, it's not clear if this extra step always helps, and there's a small concern it could put too much pressure on the knee.

This study aims to get clear answers. It will compare different types of tissue used for the graft and whether adding the LET procedure makes a difference. Researchers will look at how well the knee heals, how often people re-injure their knee, how they feel about their knee function, and if there are any side effects. By studying these things in many young, active patients, they hope to find the best way to help people recover and prevent future knee problems, improving quality of life for those with an ACL injury.

Key takeaways

Compares different ACL graft types (patellar vs. quadriceps tendon).
Investigates an additional procedure (LET) for knee stability.
Aims to reduce re-injury rates in young, active people.
Looks at long-term knee health, function, and quality of life.
Involves regular follow-up for two years after surgery.

Who may be eligible?

This study is looking for young people aged between 14 and 25 who have recently torn their Anterior Cruciate Ligament (ACL) in one knee and haven't had ACL surgery on either knee before. Your bones must have finished growing, which will be checked with X-rays.

You would be a good fit if you are active in sports that involve twisting or pivoting, or if your knee is particularly 'loose' or 'bendy' (which a doctor can measure). This study is for people who have a higher chance of re-injuring their knee.

However, you can't join if you have other serious knee injuries that need treatment, certain types of arthritis, or if you are pregnant when the study starts. You also need to be able to understand the study and agree to take part.

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 14 and 25 years old?
Do you have a recent ACL tear in one knee?
Have your growth plates (in your knees) closed?
Do you play sports involving twisting or pivoting, or does your knee feel particularly unstable?
Have you never had ACL surgery on either knee before?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have ACL surgery as you normally would. However, the type of tissue used for your new ligament (from your kneecap or quadriceps muscle) and whether you have an additional procedure called Lateral Extra-articular Tenodesis (LET) will be decided randomly, like flipping a coin. You won't get to choose these specific details.

After your surgery, you will have several follow-up appointments over two years. These appointments will involve checking your knee's stability, discussing how you are feeling, looking at your ability to move and play sports, and possibly some tests like hopping or jumping. The study aims to understand how your knee recovers and functions over this time. The total duration of your active participation, including follow-up, will be two years.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive a surgical approach that turns out to be more effective for preventing re-injury and improving long-term knee health, helping you get back to your activities. Both surgical options being studied are standard procedures for ACL repair, so you would be receiving appropriate care. Potential risks are similar to those of any knee surgery, such as infection or bleeding, and there's a small concern with the LET procedure about potentially making the joint too stiff, which the study aims to investigate. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (31)

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

Stanford University
Verified postcode
Redwood City, United States
University of California, San Francisco
Verified postcode
San Francisco, United States
Orlando Health Jewett Orthopedic Institute
Verified postcode
Orlando, United States
Med Center Health
Verified postcode
Bowling Green, United States
University of Kentucky
Verified postcode
Lexington, United States
Ochsner Clinic Foundation
Verified postcode
Baton Rouge, United States
University of Michigan
Verified postcode
Ann Arbor, United States
University of Minnesota
Verified postcode
Minneapolis, United States
Mayo Clinic
Verified postcode
Rochester, United States
University of New Mexico
Verified postcode
Albuquerque, United States
Hospital for Special Surgery
Verified postcode
New York, United States
Wake Forest University School of Medicine
Verified postcode
Winston-Salem, United States

Common questions

What is an ACL and why is it important?

The ACL is a key ligament in your knee that helps keep it stable. When it tears, your knee can feel like it's giving way, especially during sports or sudden movements.

What is 'graft choice' in ACL surgery?

Graft choice refers to the type of tissue used to replace your torn ACL. In this study, they're comparing tissue from your kneecap area (patellar tendon) and from your thigh muscle (quadriceps tendon).

What is Lateral Extra-articular Tenodesis (LET)?

LET is an additional small procedure that some surgeons believe can add extra stability to the knee after ACL reconstruction, reducing the chance of re-injury.

Will I know which type of surgery I'm getting?

No, the specific details of your surgery (graft type and whether you have LET) will be chosen randomly, like by chance, and you will not be able to decide this. This helps ensure fair comparisons in the study.

How long will I be involved in the study?

Your active involvement with follow-up appointments and assessments will be for about two years after your surgery.