Active not recruitingOBSERVATIONAL

Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

This study is being carried out by MicroPort Orthopedics to keep an eye on how a particular hip replacement device performs after it's been used in patients. This device is for a type of hip surgery called hip resurfacing, which helps people with joint pain. EU health authorities require studies like this to make sure devices are safe and work well, especially if they haven't been around for a very long time. The study will track patients for up to 10 years to see how long the device lasts, how much it improves daily activities, and what X-rays show about its position and condition in the body.

At a glance

Status

Active not recruiting

Sponsor

MicroPort Orthopedics Inc.

Enrolment target

143

Start

01 Dec 2014

Estimated completion

01 Dec 2028

Joint Disease

What is this study about?

This study is checking how well a medical device, used in hip resurfacing surgery, performs over time. Hip resurfacing is a type of operation where the damaged surface of the hip joint is replaced, but the main part of the thigh bone (femur) is kept, unlike a full hip replacement.

MicroPort Orthopedics, the company that makes this device, is carrying out this study because, in Europe, health authorities need to be sure that hip replacement and resurfacing devices are safe and effective. This is especially important for newer devices that don't yet have many years of information showing how they work in the long run. The study will follow patients who have had this device fitted for up to 10 years to gather all this important information.

The main goals of the study are to look at how long the hip device lasts, how it helps people improve their daily activities and move around better, and what X-ray scans show about the device's fit and any changes over time. This information helps doctors and regulators understand the long-term success of the device.

Key takeaways

This study evaluates a specific hip resurfacing device.
It aims to track safety and effectiveness for up to 10 years.
Participation involves follow-up appointments and X-rays.
No new treatments or medications are given during the study.
You must have already had hip resurfacing with the specific device to qualify.

Who may be eligible?

To be considered for this study, you must have already had hip resurfacing surgery using the specific device being studied. This surgery would have been to treat hip pain caused by conditions like arthritis, avascular necrosis, or a hip deformity. You also need to be willing to attend all the necessary study appointments and assessments.

You cannot join the study if you were under 21 years old when you had your hip resurfacing surgery. Also, if you're taking part in another medical study that might affect the results of this one, or if you're not able to sign the consent form, you wouldn't be able to participate. The study also excludes individuals with substance abuse issues or those who are in prison or have legal issues that might lead to being in prison.

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.

Have you had hip resurfacing surgery for hip pain?
Was your hip resurfacing with the specific device being studied?
Were you 21 years old or older when you had the surgery?
Are you able and willing to attend study appointments?
Are you currently not enrolled in another medical study that might affect this one?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll have specific check-ups and assessments over a period of up to 10 years after your hip resurfacing surgery. These check-ups will likely involve answering questions about your hip function and pain, and having X-rays taken to see how your hip implant is doing. You won't be given any new medication as part of this study; it's purely about observing how patients do after their surgery. The exact number and timing of visits will be explained, but the study aims to follow you for a long time to see the device's long-term performance.

Potential risks and benefits

Taking part in this study means your health and surgical outcome will be carefully monitored over many years, which could provide you with detailed information about your hip. However, there are no direct medical benefits from participating beyond the usual care you would receive. The risks are generally low, mainly involving the time and effort needed for study visits and assessments, which might include inconvenience from travel or taking time off work. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Ottawa Hospital
Verified postcode
Ottawa, Canada

Common questions

What is hip resurfacing?

Hip resurfacing is a type of hip operation that replaces the damaged surface of the hip joint with metal caps, while keeping most of your own bone.

Why is this study happening?

This study is happening to check how safe and effective a specific hip resurfacing device is over many years, which is required by health authorities in Europe.

Will I get any new medicine or treatment?

No, this study only observes how patients are doing with the hip device they already have; no new medicines or treatments are given.

How long will I be in the study?

You will be followed for up to 10 years, with regular check-ups to monitor your hip and the device.

Can I leave the study early?

Yes, you can choose to leave the study at any time, and this will not affect your medical care.