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Procedure

3D Printing + Conventional Imaging for Hip Surgery Planning

N/A

Waitlist Available

Led By Ivan Wong, Dr.

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with type III or IV heterotopic ossification

Patients with nonvascular surgical sites (MRI proven)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in pre-op measurements compared to 24 months post-operatively

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether 3D printed models can help with planning for arthroscopic FAI surgery. Patients will be randomly assigned to either have just conventional imaging or to have a 3D printed model in addition.

Who is the study for?

This trial is for individuals with a confirmed diagnosis of cam-type femoroacetabular impingement (FAI) using radiology. It's not suitable for those who are pregnant, unable to consent, have infections, don't understand post-op care, have cancer or advanced arthritis, heterotopic ossification types III/IV, need revision surgery, nonvascular surgical sites or avascular necrosis.

What is being tested?

The study compares two approaches in planning hip preservation surgery: one group uses standard imaging techniques like X-ray and MRI only; the other group gets a personalized 3D printed model based on these images as well. Patients will be randomly assigned to either group.

What are the potential side effects?

Since this trial focuses on preoperative planning methods rather than medications or invasive procedures directly administered to patients, there are no direct side effects from the interventions being tested.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have advanced heterotopic ossification.

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My surgery site is not related to blood vessels, confirmed by MRI.

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I have avascular necrosis.

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I have severe arthritis as shown by my X-rays.

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I cannot follow or understand post-surgery instructions.

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I am scheduled for a second hip surgery to correct a previous one.

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I am unable to understand and give consent for my treatment.

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I currently have an infection.

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I have a hip cartilage injury larger than 1cm2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in pre-op measurements compared to 24 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in pre-op measurements compared to 24 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in pre-op measurements compared to 24 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure of CAM resection

Secondary study objectives

Differences in post-operative patient reported outcomes: EQ5D

Differences in post-operative patient reported outcomes: EQ5D-VAS

Differences in post-operative patient reported outcomes: HOS-Sport

+4 more

Other study objectives

The number of times conventional imaging and 3D prints are referenced intra-operatively.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Conventional ImagingExperimental Treatment1 Intervention

Patients in this group allocation will receive conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.

Group II: 3D Print + Conventional imagingExperimental Treatment1 Intervention

Patients in this group allocation will receive a 3D reconstruction of their hip in addition to conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.

0 / 9Eligibility criteria met