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Enrolling by invitationNAINTERVENTIONAL

The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery

This study, taking place in Canada, is investigating if using 3D printed models of a patient's hip can improve the success of hip surgery for a condition called femoroacetabular impingement (FAI). FAI is a hip problem where extra bone causes pain and limits movement. Patients will be randomly put into two groups: one where surgeons plan the operation using standard scans like X-rays and MRI, and another group where surgeons also use a detailed 3D printed model of the hip. The aim is to see if these models help surgeons get a better understanding of each patient's hip anatomy before surgery, potentially leading to better results and fewer repeat operations.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
Nova Scotia Health Authority
Enrolment target
80
Start
01 Jan 2021
Estimated completion
30 Jun 2027

What is this study about?

This study is looking at a common hip problem called femoroacetabular impingement, or FAI. This happens when the bones of the hip joint grow in a way that causes them to rub against each other, leading to pain and stiffness. When surgery is needed to fix this, doctors usually plan the operation using images like X-rays, MRI scans, and CT scans.

This study wants to find out if adding something new to this planning process can make the surgery even more successful. The new item is a 3D printed model of the patient's hip. Imagine having a physical model of your own hip that a surgeon can hold and look at from all angles before the operation. The idea is that this detailed, touchable model might give the surgeon a clearer picture of the problem area than just looking at scans on a screen.

Patients taking part will be randomly assigned to one of two groups. One group will have their surgery planned using the usual scans. The other group will have their surgery planned using both the usual scans AND the special 3D printed model. The researchers will then compare the results of the surgery in both groups to see if the 3D models helped improve outcomes or reduce the need for further operations later on.

Key takeaways

  • Study examines using 3D printed hip models for FAI surgery planning.
  • Compares standard planning vs. planning with an added 3D model.
  • Aims to improve surgical success and reduce repeat operations.
  • Involves standard scans and questionnaires, no extra treatments.
  • Participation is voluntary and you can withdraw anytime.

Who may be eligible?

This study is looking for adults aged 18 or over, male or female, who have a specific type of hip problem called cam-type femoroacetabular impingement (FAI). This diagnosis must have been confirmed by scans like X-rays and MRI.

However, there are certain reasons why someone might not be able to join the study. For example, if you have severe arthritis in your hip, significant cartilage damage, or another hip condition called avascular necrosis, you would not be suitable.

Also, if you are pregnant, have an infection, have cancer, or have trouble understanding and following instructions after surgery, you wouldn't be able to participate. This study is for people having their first hip surgery for FAI, not those having repeat surgery.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with cam-type femoroacetabular impingement (FAI)?
  3. Are you NOT pregnant?
  4. Do you NOT have severe hip arthritis, significant cartilage damage, or an infection?
  5. Are you having hip surgery for FAI for the first time?
  6. Can you understand and follow instructions after surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will be quite straightforward. First, you'll meet with the surgeon or a member of the research team to discuss all the details, including the potential benefits and risks. If you're interested, you'll be given some information to read and think about before giving your consent.

Once you've joined, you'll have all the standard scans needed for your FAI surgery, including X-rays, an MRI, and a CT scan. These are routine for this type of surgery, so you won't have any extra radiation exposure beyond what's normally required. You'll also have a check-up with a sports medicine doctor and fill out some questionnaires about your hip pain and function.

Crucially, you'll be randomly assigned to one of two groups for your surgery planning – either the standard planning group or the group that also uses a 3D printed model. The study won't require any additional time from you beyond the initial consent discussion and the standard pre-operative assessments that would happen anyway for your surgery. The researchers will then follow up on your progress after surgery to see how well the operation went.

Potential risks and benefits

Taking part in this study means you'd be contributing to valuable research that could help improve hip surgery for many people in the future. The main potential benefit is that using a 3D printed model might lead to a more precisely planned surgery, potentially resulting in better outcomes and a lower chance of needing another operation. However, there's no guarantee that you will personally benefit. The risks involved are generally very low, as the standard procedures for your hip surgery will remain the same. You won't have any extra X-rays or scans just for the study. The main additional step is the consent process. Remember, you can decide to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • 5955 Veterans' Memorial Lane Room 2106, VMB
    Verified postcode
    Halifax, Canada

Common questions

What is FAI?

FAI stands for femoroacetabular impingement. It's a hip problem where the bones rub against each other, causing pain and limiting movement.

Will I have extra scans for this study?

No, you'll only have the usual X-rays, MRI, and CT scans that are normally needed for your FAI surgery.

What is a 3D printed model?

It's a physical, plastic model created from your scans, showing a detailed copy of your hip bones that your surgeon can hold and examine.

Will I know if my surgeon uses a 3D model?

You will be randomly assigned to a group, so you won't choose whether a 3D model is used. The researchers will then track your progress.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The Innovation of 3D Printing for Preoperative Planning in H…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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