3D Printing + Conventional Imaging for Hip Surgery Planning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Advanced arthritis, Cartilage delamination, Avascular necrosis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a 3D printed model of the hip, alongside regular imaging like X-rays and MRIs, improves planning for hip surgeries to treat femoroacetabular impingement (FAI). FAI occurs when extra bone grows along one or both bones forming the hip joint. Participants will join one of two groups: one will use only conventional imaging, while the other will also use a 3D model. The trial seeks individuals diagnosed with cam-type FAI, excluding those with advanced arthritis or significant hip damage. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical planning and outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D printing technique is safe for hip surgery planning?

Research has shown that using 3D printed models to plan hip surgeries can be safe and helpful. In past studies, doctors used these models to prepare for surgeries, which improved planning and allowed them to try out procedures in advance. This approach led to better outcomes without causing additional harm to patients.

Using 3D printing for surgery planning has not been linked to any major negative effects. Instead, it appears to enhance surgical accuracy. For patients, this means a better chance of a successful surgery with fewer unexpected issues during the procedure. While any medical tool can carry risks, current research suggests that 3D printed models are generally safe for patients when used in surgery planning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D printing alongside conventional imaging for hip surgery planning because it offers a more detailed and personalized approach. Unlike standard imaging methods like X-rays, CTs, and MRIs, which provide 2D or sectional views, 3D printing creates a tangible model of the patient's hip. This allows surgeons to visualize and plan the procedure more accurately, potentially improving surgical outcomes. By having a physical model, surgeons can better anticipate challenges and tailor their surgical approach to each individual's unique anatomy.

What evidence suggests that 3D printing is effective for hip surgery planning?

This trial will compare the use of 3D printed models combined with conventional imaging to conventional imaging alone for hip surgery planning. Research has shown that using a 3D printed model alongside regular imaging can enhance hip surgery planning. Studies have found that these models provide surgeons with a clearer understanding of the hip, potentially leading to more accurate surgeries. Specifically, 3D models have changed how surgeons plan for femoroacetabular impingement, a condition where hip bones rub together. This could result in fewer complications and better outcomes for patients. Overall, early evidence suggests that adding a 3D model to traditional imaging offers a clearer view, which might improve surgical success. ^{2 5 6 7 8}

Who Is on the Research Team?

Ivan Wong, Dr.

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI)

Exclusion Criteria

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

I have advanced heterotopic ossification.

I have avascular necrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Planning

Participants undergo routine pre-operative imaging and are randomized into groups with or without 3D printed models for planning hip arthroscopy

No additional time requirements

1 visit (in-person)

Surgery

Participants undergo hip arthroscopy for the treatment of femoroacetabular impingement (FAI)

During surgery only

Follow-up

Participants are monitored for safety and effectiveness after surgery, with outcomes measured up to 24 months post-operatively

24 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 3D Print + Conventional imaging
• Conventional imaging

Trial Overview 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.

How Is the Trial Designed?

Group I: Conventional Imaging Experimental Treatment 1 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 imaging Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2059775425006200

Use of Custom Three-Dimensionally Printed Models ... The purpose of this study was to investigate whether the use of a 3D printed model, compared to conventional imaging, resulted in better ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10090017/

A three-dimensional (3D) printed simulator as a feasible ... This study demonstrated that a reliable hip arthroscopic simulator can be developed for use by orthopedic surgeons to evaluate their hip arthroscopic skills.

3. ajronline.org ajronline.org/doi/10.2214/AJR.17.19400

Preoperative Use of a 3D Printed Model for Femoroacetabular ... In this study, we found that 3D models alter preoperative planning for osteoplasty in FAI surgery. Failed arthroscopic hip surgery may require repeat ...

4. mdpi.com mdpi.com/2077-0383/13/2/599

Clinical Applications of “In-Hospital” 3D Printing in Hip ... The aim of the study is to describe all the current applications of 3D printing in patients undergoing hip surgery of any type at the present time.

5. academic.oup.com academic.oup.com/jhps/article/6/2/164/5513241

Application of three-dimensional printing for pre-operative ... In this study, we illustrated the way 3D models of the hip are built, described our use of 3D models in hip preservation surgery, and reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7054078/

Three-dimensional-printing Technology in Hip and Pelvic ... Simulation surgery using a 3D-printed bone model allows surgeons to develop better surgical approaches, test the feasibility of procedures and determine optimal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005768/

Development of a simulation system for femoroacetabular ... This study developed a CT image–based dynamic criterion to effectively simulate FAI, thereby providing a basis for physicians to perform pre-operative planning ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025002102

Clinical Outcomes of 3D-Guided Ganz Periacetabular ... Our results are consistent with those of other studies, in that 3D imaging and modeling helped to improve acetabular coverage (LCEA increase, ...