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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 3D Print + Conventional imaging for hip surgery planning?

Research shows that 3D printed models are useful and reliable for surgical planning, as demonstrated in a study with a strong correlation between the printed models and actual patient images. This suggests that using 3D printing alongside conventional imaging can enhance the accuracy and effectiveness of planning hip surgeries. ^{1 2 3 4 5}

Is 3D printing technology safe for use in hip surgery planning?

Research on 3D printing for hip surgery planning, including studies on children and adults with hip dysplasia, shows it is generally safe, with no significant increase in radiation or blood loss compared to traditional methods. ^{6 7 8 9 10}

How does the treatment 3D Print + Conventional imaging for hip surgery planning differ from other treatments?

This treatment is unique because it uses 3D printed models created from conventional imaging like CT scans to provide a detailed and accurate surgical plan, which helps in selecting the right equipment and anticipating potential complications before surgery. This approach allows for better preparation and can streamline the surgical process compared to traditional methods that rely solely on 2D imaging. ^{6 11 12 13 14}

What is the purpose of this trial?

This is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement (FAI) surgery. The RCT will look to place patients into one of two treatment groups: 1) conventional preoperative imaging (X-ray, CT, and MRI) only and 2) those that have had a 3D printed model created in addition to the conventional imaging.

Research Team

Ivan Wong, Dr.

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing cost and print time estimates for six commercially-available 3D printers obtained through slicing software for clinically relevant anatomical models. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Application of 3D printing and computer-assisted surgical simulation in preoperative planning for acetabular fracture]. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Application of 3D-printed osteotomy guides in periacetabular osteotomy: A short-term clinical study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Using a 3D Printed Model as a Preoperative Tool for Pelvic Triple Osteotomy in Children: Proof of Concept and Evaluation of Geometric Accuracy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Preliminary application of 3D-printed individualised guiding templates for total hip arthroplasty in Crowe type IV developmental dysplasia of the hip. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

3D PRINTING APPLICATION IN BONE DEFECT AREA MEASUREMENT ON PATIENTS WITH DEVELOPMENTAL DYSPLASIA OF THE HIP. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of 3D Printing Technology in Proximal Femoral Osteotomy in Children with Developmental Dysplasia of the Hip. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Application of computer-aided design and 3D-printed navigation template in Locking Compression Pediatric Hip PlateΤΜ placement for pediatric hip disease. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Application of 3D printing guide plate in total hip arthroplasty for developmental dysplasia of the hip]. [2020]

10. England pubmed.ncbi.nlm.nih.gov

3D-printed models for periacetabular osteotomy surgical planning. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

3D Printed Patient-Specific Complex Hip Arthroplasty Models Streamline the Preoperative Surgical Workflow: A Pilot Study. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A paradigm shift in surgical planning and simulation using 3Dgraphy: Experience of first 50 surgeries done using 3D-printed biomodels. [2022]

13. Italy pubmed.ncbi.nlm.nih.gov

The use of 3D printed models for the pre-operative planning of surgical correction of pediatric hip deformities: a case series and concise review of the literature. [2022]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Three-dimensional-printing Technology in Hip and Pelvic Surgery: Current Landscape. [2020]