Active not recruitingNAINTERVENTIONAL

Radiographic Migration Analysis of the Insignia Hip Stem

This study is investigating a specific type of hip replacement called the Insignia hip stem. We want to understand how this new hip stem settles and connects with your bone after surgery. This is important to ensure it lasts well. We'll be using special scans, including X-rays and CT scans, to measure any small movements of the hip stem over the first two years. Another aim is to compare a newer CT scanning method with the standard X-ray method to see if they both give similar, accurate results. We'll also ask patients about their hip function and how satisfied they are with their new hip. Around 30 patients who need a total hip replacement due to arthritis will be invited to participate.

At a glance

Status

Active not recruiting

Phase

Sponsor

Canadian Radiostereometric Analysis Network

Enrolment target

Start

15 Jan 2025

Estimated completion

01 Dec 2027

Hip Implant Hip Replacement in Osteoarthritis Patients Migration of Implant

What is this study about?

Imagine you're having a hip replacement because your hip joint is worn out from arthritis. This study is all about a particular type of artificial hip part, called the Insignia hip stem, which is placed inside your thigh bone during the operation. We want to carefully check how well this new hip stem settles into your bone over the first two years after your surgery. This is important because if the hip stem moves too much, it might not last as long as it should.

To do this, we'll be using special scanning techniques. One is called Radiostereometric Analysis (RSA), which uses X-rays to create very detailed 3D images and can detect even tiny movements. We'll also use a type of CT scan to see if it can provide similar information about the stability of the hip stem. By comparing these two scanning methods, we hope to find out if the CT scan can be just as good as the traditional RSA method for monitoring the hip stem. We'll also be asking you about how your hip is feeling and how well you can move.

About 30 patients who are having their first total hip replacement due to severe arthritis will be invited to join. The main goal is to make sure the Insignia hip stem is stable and to see if a newer, perhaps easier, way of scanning can accurately check this. Your participation would help us learn more about how well this type of hip replacement works and to improve future care for people needing hip surgery.

Key takeaways

This study evaluates how a specific hip replacement, the 'Insignia hip stem', settles into the bone.
It uses special scans (X-rays and CT scans) to detect tiny movements of the hip part.
The study also compares a new CT scanning method with current X-ray techniques.
Around 30 patients having their first hip replacement for arthritis will participate.
Your involvement would be for about two years after your surgery, with extra appointments for scans.
You would also fill out questionnaires about how your new hip is working and how you feel about it.

Who may be eligible?

To be able to join this study, you need to be an adult, aged 21 or older, and have severe hip arthritis that means you need your first total hip replacement. You should also be happy and able to come to all the follow-up appointments and fill out questionnaires as requested. Importantly, you need to be able to understand the study information and agree to take part.

There are some reasons why you wouldn't be able to join. For example, if you currently have an infection or have had one in the past that affected your hip, or if you have other serious health problems that mean major surgery might not be safe for you. If you've had previous surgery on your hip that involved putting metalwork in, or if you have certain skin conditions where the surgeon needs to make the cut, you also wouldn't be eligible.

People with conditions like severe curvature of the spine (ankylosing spondylitis) or specific types of previous leg bone surgery (shortening osteotomy) also cannot take part. The study needs participants who are generally healthy enough for surgery and who are likely to remain so for at least the next two years.

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 21 years old or older?
Are you having your first total hip replacement for arthritis?
Are you willing and able to come to all follow-up appointments for two years?
Do you feel healthy enough for major surgery and likely to stay well for two years?
Have you not had previous hip surgery that left metal in your hip?
Do you not have a current infection or certain skin conditions near your hip?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be having your hip replacement surgery as planned using the Insignia hip stem. Before and after your surgery, you would have some extra scans, including special X-ray scans (RSA) and CT scans, to monitor your new hip. These scans would be done at various times during the first two years after your operation to check how well the hip stem is settling in. You would also be asked to complete questionnaires about your hip function and how satisfied you are with your new hip. There are no additional medications involved in this study. The total duration of your participation would be about two years, involving several follow-up appointments.

Potential risks and benefits

Taking part in this study might mean you get a closer look at how your hip replacement is settling in after surgery through the extra scans. This could provide valuable information to your medical team. However, there are no direct health benefits to you in terms of your treatment, as you would be having the same hip replacement as planned. There are some minor risks, such as the very small amount of radiation exposure from the extra scans, which your doctor can discuss with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Concordia Hip & Knee Institute
Verified postcode
Winnipeg, Canada

Common questions

What is an Insignia hip stem?

It's a specific type of artificial part of the hip joint that replaces the top of your thigh bone during hip replacement surgery.

Why are you doing extra scans?

We want to see how well the Insignia hip stem settles into your bone and to compare a new type of CT scan with the standard X-ray method for monitoring it.

Will taking part change my hip replacement operation?

No, your hip replacement operation will be done as planned. You'll just have some extra scans and questionnaires as part of the study.

How long will I need to be involved in the study?

You will be involved for about two years after your hip replacement surgery, with several follow-up appointments for scans and questionnaires.

Can I stop taking part if I change my mind?

Yes, you can decide to leave the study at any time without giving a reason, and it won't affect your medical care.