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

NCT04505020 · tracked via the Priya Life Science Canada tracker

Sponsor

Nova Scotia Health Authority

Phase

Not applicable

Started

2021-01-01

Last updated

2025-02-17

Condition(s) studied

Femoro Acetabular Impingement

Investigational drug(s) / intervention(s)

3D Print + Conventional imagingConventional imaging

3D Print + Conventional imaging: This group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging.

Conventional imaging: This group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI) Exclusion Criteria: * Patients with advanced arthritis (Tonnis Grade III or Kellgren-Lawrence Grade III or IV or evidence of less than 2 mm of joint space, as determined by conventional radiographs.) * Patients with 1cm2 (or greater) of cartilage delamination in the hip * Patients with type III or IV heterotopic ossification * Patients with avascular necrosis * Patients who are unable to provide informed consent * Patients who are undergoing revision hip arthroscopy * Patients who are pregnant * Patients who have the presence of local or systemic infection * Patients with an inability to cooperate with and/or comprehend post-operative instructions * Patients with nonvascular surgical sites (MRI proven) * Patients with cancer

Primary outcome measure(s)

Measure of CAM resection — Change in Pre-op measurements compared to 2 weeks post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measure of CAM resection — Change in Pre-op measurements compared to 6 months post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
Measure of CAM resection — Change in Pre-op measurements compared to 24 months post-operatively
Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.

Trial sites (1)

Facility	City	Region	Status
5955 Veterans' Memorial Lane Room 2106, VMB	Halifax	Nova Scotia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04505020 on ClinicalTrials.gov ↗ ← All trials in Canada