Active not recruitingNAINTERVENTIONAL

Unicompartmental Versus Total Knee Replacement for Medial Compartment Knee Osteoarthritis

If you have arthritis in just one part of your knee, doctors can offer you either a partial knee replacement or a full one. Both are good treatments, but it's not clear which is best for everyone. Partial replacements save more of your natural knee and often mean a faster recovery. This study, called FLEX-UNI, will look closely at how patients move after each operation. We'll use special 3D cameras to track movement during everyday activities like walking, climbing stairs, and stepping down from a step. Forty patients will take part, being randomly chosen for one operation. We hope to learn which type of surgery leads to better knee function a year later.

At a glance

Status

Active not recruiting

Phase

Sponsor

Golden Jubilee National Hospital

Enrolment target

Start

26 Apr 2021

Estimated completion

15 Oct 2027

Osteoarthritis Knee Arthroplasty Replacement, Knee

What is this study about?

If you're dealing with arthritis in your knee, specifically when it affects only the inner part, your doctor might discuss two main types of surgery: a partial knee replacement or a total (full) knee replacement. A partial knee replacement fixes just the worn-out part, leaving more of your natural knee untouched. This can sometimes lead to a quicker recovery. A total knee replacement, on the other hand, replaces the entire joint. Both surgeries are common and help many people, but doctors don't always agree on when to choose one over the other, especially for arthritis that's only in one area.

Past studies have often asked patients how they feel their knee is doing, but these surveys might not show the full picture of how the knee actually works. Other studies have measured movement, but mostly just during simple walking, which might not be challenging enough to see real differences between the operations. Many patients find that going up and down stairs remains a challenge for a long time after knee surgery. This suggests we need to look at more demanding activities to understand which operation is truly better for day-to-day life.

This study, called FLEX-UNI, aims to find out which operation leads to better movement and function. We will use advanced 3D motion cameras to carefully measure how your knee moves during activities like walking, climbing stairs, walking on slopes, sitting down, standing up, and importantly, stepping down from a step. Forty patients who are suitable for a partial knee replacement will be randomly chosen to receive either a partial or a full knee replacement. The main thing we'll be looking at is how much your knee bends when stepping down from a step one year after your surgery. We'll also ask you questions, take X-rays, and check for any problems.

Key takeaways

This study compares partial vs. total knee replacement for specific knee arthritis.
It uses 3D sensors to measure movement, not just questionnaires.
The main focus is on how well you can move during demanding tasks like stepping down.
Participants will be randomly assigned to one of the two surgeries.
You will be followed for 12 months after your operation.
The goal is to find out which operation leads to better long-term function.

Who may be eligible?

This study is looking for people aged between 18 and 75 years old who need knee replacement surgery because of arthritis in only the inner part of their knee. You would need to be suitable for a partial knee replacement and have a healthy anterior cruciate ligament, which is an important ligament in your knee. You also need to be at least 1.5 meters tall and have a body mass index (BMI) under 40.

There are certain conditions that would mean you couldn't take part. For example, if you have other types of arthritis like rheumatoid arthritis, or if you've had hip surgery in the last year, or if you've had previous knee surgery (apart from keyhole surgery or a small tidy-up of a cartilage tear). Problems with your foot, hip, or spine that cause pain or make it hard to walk, or certain serious medical conditions that affect walking, would also mean you couldn't join. You must also be able to understand English or bring someone who can translate for you at all study visits, and be able to return to the study centre for follow-up appointments.

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 18 and 75 years old?
Do you have arthritis only in the inner part of your knee?
Are you suitable for a partial knee replacement?
Can you come back for follow-up appointments at the study centre?
Do you weigh less than 40 on the BMI scale?
Do you not have other conditions like rheumatoid arthritis or recent hip/knee surgery (other than minor scope/menisectomy)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a chat with the research team and your surgeon to make sure the study is right for you. If you agree, you'll sign a consent form. Then, before your operation, we'll do some basic checks and measurements. You'll then be randomly assigned to receive either a partial or a full knee replacement. Neither you nor the researchers who measure your movement will know which operation you've had; this helps us get unbiased results.

After your surgery, we'll ask you to come back to the study centre for follow-up appointments over 12 months. During these visits, we'll use special cameras to measure your knee movement during activities like walking, stepping, and climbing stairs. We'll also ask you to fill in some questionnaires, take X-rays, and check how you're recovering. This will help us compare the two operations and see which one helps patients move best. You will not be taking any new or different medications as part of this study.

Potential risks and benefits

Taking part in this study could help future patients by providing important information about which knee replacement surgery is best for certain types of arthritis. You will receive expert surgical care, and your recovery will be carefully monitored. The risks involved are those typically associated with knee replacement surgery, such as infection, bleeding, or problems with the new joint, as well as the usual risks of any surgery. There are no additional surgical risks from being in the study itself, as both operations are standard treatments. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Golden Jubilee National Hospital
Verified postcode
Clydebank, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to compare how well patients move and function after a partial knee replacement versus a total knee replacement, especially during activities like stepping down and climbing stairs.

How will I know which surgery I will have?

You will be randomly assigned to either a partial or a total knee replacement. You will not know which one you're having until after the operation, and neither will the researchers doing the movement tests.

Will I have to do anything differently for my recovery?

No, your rehabilitation and recovery after surgery will be the same as for other patients having the same type of knee replacement. You will not be asked to take any special medications.

How long will I be involved in the study?

You will be followed for 12 months after your surgery, with visits to the study centre for measurements and check-ups during that time.

What happens if I change my mind during the study?

You can withdraw from the study at any time, for any reason, without it affecting your medical care or your relationship with your healthcare team.