Active not recruitingNAINTERVENTIONAL

REDAPT Revision Hip System With RSA

This study is investigating a new hip replacement system, called REDAPT, designed for people who need a revision hip surgery. This means replacing parts of an existing hip replacement. Doctors want to see how securely the new hip stem (the part that goes into the thigh bone) and the cup (the socket part in the pelvis) stay in place over two and five years after surgery. They will also assess how much pain and movement improve for patients, and whether there are any problems visible on X-rays. The study aims to understand the success of the REDAPT system in helping patients recover and improve their hip function.

At a glance

Status

Active not recruiting

Phase

Sponsor

Orthopaedic Innovation Centre

Enrolment target

Start

15 Jan 2019

Estimated completion

31 Dec 2027

Hip Osteoarthritis

What is this study about?

This research is looking into a new type of hip replacement system called REDAPT. This system is used when people need to have their existing hip replacement revised, which means replacing some or all of the artificial hip parts that were put in during a previous surgery. The main goal is to check how well the two main parts of the REDAPT system – the stem, which goes into your thigh bone, and the cup, which connects to your pelvis – stay firmly in place over time. They will specifically check this at two and five years after your revision surgery using special X-ray techniques.

Beyond just how stable the new parts are, the study also wants to see how things change between the first year and five years after your operation. Importantly, they will measure how much your hip function and overall health improve after having the REDAPT system installed. This involves looking at things like pain levels, your ability to move, and how easily you can do daily activities. They will also examine X-rays to look for any signs of loosening or other issues around the hip parts.

The study will include patients who need different types of revision surgery – some will have just the stem replaced, some just the cup, and some both. By looking at these different groups, the researchers hope to understand when the REDAPT system works best and how its stability might be affected by the specific type of revision surgery you have.

Key takeaways

The study looks at how well a new hip replacement system, REDAPT, works for revision surgery.
It checks the stability of the new hip parts and how much patients improve over five years.
Participation involves revision hip surgery and follow-up visits for up to five years.
It aims to understand the long-term success of the REDAPT system.
Your health and safety are the top priority, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and require hip revision surgery, which means replacing either the stem or the cup of your existing hip replacement, or both. You must be able to use the specific REDAPT hip device and be willing and able to come to all the follow-up appointments and complete any questionnaires or evaluations required by the study. Most importantly, you must be able to understand the study and agree to take part.

There are several reasons why you might not be able to join. For example, if you have an active hip infection that requires immediate treatment, or if you're undergoing the first stage of a two-stage revision surgery for an infection, you wouldn't be eligible. Also, if you know you have an allergy to metals used in the device components, or if you have certain severe underlying health conditions like severe obesity (BMI over 40) or inflammatory joint disease, you wouldn't be included. If you've recently taken part in another clinical study or live too far from the hospital to attend follow-up visits, you might also not qualify. The study also has specific requirements about the type of artificial hip joint surfaces and stem lengths that can be used, and if your needs fall outside these, you won't be able to participate.

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 18 years old or older?
Do you need revision hip surgery (replacing old hip parts)?
Are you able to attend all planned follow-up appointments for five years?
Do you not have an active infection in your hip?
Do you not have severe obesity or inflammatory joint disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo revision hip surgery where the REDAPT hip system will be used to replace your hip components. After your surgery, you will have regular follow-up appointments over a period of five years. These appointments will involve check-ups, special X-rays (called RSA) to measure how well the hip parts are staying in place, and completing questionnaires about your hip function, pain levels, and overall health. You will have these assessments at specific times, including at 2 years and 5 years after your surgery. The full duration of your participation in the study, including all follow-up visits, will be approximately five years.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that you would receive the REDAPT revision hip system, which is being carefully monitored to assess its performance. The detailed follow-up means your recovery and the stability of your hip components will be closely observed. However, as with any surgery, there are risks associated with hip revision surgery itself, such as infection, blood clots, or nerve damage, which would be explained to you by your orthopaedic surgeon. There may also be unknown risks associated with receiving a newer device. Your rights, safety, and well-being are paramount, and you are free to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Concordia Hospital
Verified postcode
Winnipeg, Canada

Common questions

What is a 'revision hip system'?

A revision hip system is used when parts of an existing artificial hip replacement need to be replaced, often because they have worn out or become loose.

What is 'RSA' and why is it used?

RSA is a special type of X-ray that helps doctors very accurately measure tiny movements of the hip parts, to see if they are staying firmly in place over time.

Will I get both parts of my hip replaced in this study?

Not necessarily. The study includes people who need either the stem, the cup, or both parts of their hip replacement revised.

How long will I be followed in this study?

You will be followed up for a total of approximately five years after your revision hip surgery.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study or for the study-related procedures and assessments.