Active not recruitingNAINTERVENTIONAL

Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

This long-term study is for people having a total knee replacement because of knee arthritis. Doctors want to compare two common types of knee replacement surgery: one called 'cruciate-retaining' (CR) and another called 'cruciate-substituting' (PS). The main goal is to see which type allows people to bend their knee better after surgery. They will also look at how patients feel and function in their daily lives, using special questionnaires. Patients will be randomly assigned to receive one of the two types of knee replacement and will be checked regularly for up to ten years after their operation.

At a glance

Status

Active not recruiting

Phase

Sponsor

Technische Universität Dresden

Enrolment target

140

Start

01 Apr 2018

Estimated completion

01 Sep 2030

Knee Osteoarthritis

What is this study about?

When you have severe knee arthritis, a total knee replacement (TKA) can help relieve pain and improve movement. There are different designs of these artificial knees. This study focuses on two main types: one called 'cruciate-retaining' (CR) and another called 'cruciate-substituting' (PS).

The 'cruciate' part refers to important ligaments inside your knee. In a CR knee replacement, your own posterior cruciate ligament is kept. In a PS knee replacement, this ligament is removed, and the artificial knee takes over its job. Doctors want to understand if one type of design works better than the other, especially when it comes to how much you can bend your knee after the surgery.

To find this out, they will measure how far you can bend your knee before your operation, and then again many times over the next ten years. They will also ask you to fill out questionnaires about your pain, daily activities, and general quality of life. This information will help doctors understand which type of knee replacement might be the best option for future patients.

Key takeaways

Compares two common types of total knee replacement surgery.
Aims to understand which type leads to better knee bending and patient wellbeing.
Participants will undergo their planned knee replacement surgery.
You'll have regular follow-up appointments for up to 10 years.
Helps doctors improve future knee replacement treatments.

Who may be eligible?

This study is looking for adults who are planning to have a total knee replacement because of knee arthritis. You need to be able to understand the study and agree in writing to take part. There's no upper age limit, meaning people of all adult ages can be considered.

However, there are certain reasons why you might not be able to join. For instance, if you have ongoing widespread pain, certain nerve or muscle conditions, or other serious health issues that would make it hard to attend follow-up appointments, you wouldn't be able to participate. Also, if you have a specific problem with a ligament in your knee that would mean you definitely need the PS type of knee replacement, or if you need a more complex type of knee replacement, this study wouldn't be right for you.

People with a very high body mass index (BMI over 40) are also not suitable for this study. Lastly, if you are a member of the study doctor's family or staff, you cannot take part, to ensure the study is fair and unbiased.

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 an adult planning to have a total knee replacement for arthritis?
Do you feel fit enough to attend regular follow-up appointments for up to 10 years?
Do you not have certain nerve or muscle conditions?
Is your body mass index (BMI) 40 or below?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to read and sign a consent form. Before your operation, the doctors will measure how well you can bend and straighten your knee using a simple tool. You will also fill out some questionnaires about your knee and general health.

During your surgery, you will be randomly assigned to receive either the CR or the PS type of total knee replacement. After your surgery, you will have follow-up appointments at 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years. At each of these visits, your knee movement will be measured again, and you'll be asked to complete the same questionnaires. The total duration of your involvement in the study could be up to ten years.

Potential risks and benefits

Potential benefits of participating include playing a part in research that could improve knee replacement surgery for others in the future. You will also receive regular follow-up on your knee for up to ten years. There are no additional risks beyond those normally associated with total knee replacement surgery. As with any study, you are free to withdraw at any time without giving a reason, and this will not affect your medical care.

Locations (1)

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Verified postcode
Dresden, Germany

Common questions

What is knee arthritis?

Knee arthritis is a common condition where the smooth cartilage protecting the ends of your bones wears away, causing pain, stiffness, and difficulty moving your knee.

What is a total knee replacement?

It's an operation where damaged parts of your knee joint are removed and replaced with artificial parts, usually made of metal and plastic, to reduce pain and improve movement.

What does 'randomly assigned' mean?

It means a computer or system will choose which type of knee replacement you receive, like flipping a coin. Neither you nor your doctor will get to choose.

Will I know which knee replacement I received?

Yes, your medical team will know, and they can tell you which type of knee replacement you received.

How long will I be involved in the study?

You will be followed for up to 10 years after your surgery, with several check-up appointments during that time.