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

NCT04505020 | Enrolling By Invitation

• 1 other identifier: 3DPRINT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femoro Acetabular Impingement

Keywords

Femoroacetabular Impingement; Cam lesion; 3D printing; Pre-operative planning

Outcome Measures

Primary Outcomes (3)

• Measure of CAM resection

  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.

  Change in Pre-op measurements compared to 2 weeks post-operatively

• Measure of CAM resection

  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.

  Change in Pre-op measurements compared to 6 months post-operatively

• Measure of CAM resection

  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.

  Change in Pre-op measurements compared to 24 months post-operatively

Secondary Outcomes (7)

• Differences in post-operative patient reported outcomes: iHOT-33

  Change in outcomes 24 months post operatively compared to Pre-operatively

• Differences in post-operative patient reported outcomes: NAHS

  Change in outcomes 24 months post operatively compared to Pre-operatively

• Differences in post-operative patient reported outcomes: EQ5D

  Change in outcomes 24 months post operatively compared to Pre-operatively

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

  Change in outcomes 24 months post operatively compared to Pre-operatively

• Differences in post-operative patient reported outcomes: VR-12

  Change in outcomes 24 months post operatively compared to Pre-operatively

Other Outcomes (1)

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

  During surgery only

Study Arms (2)

3D Print + Conventional imaging

EXPERIMENTAL

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.

Other: 3D Print + Conventional imaging

Conventional Imaging

OTHER

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.

Other: Conventional imaging

Interventions

3D Print + Conventional imaging OTHER

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.

3D Print + Conventional imaging

Conventional imaging OTHER

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.

Conventional Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

5955 Veterans' Memorial Lane Room 2106, VMB

Halifax, Nova Scotia, B3H 2E1, Canada

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Wong, Dr.

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded/masked to the treatment (if they do or don't receive a 3D printed model of their hip) they receive until the end of the study. Patients will still be aware of the details of their surgical treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients that have consented to the study will be randomized into four groups with a 50% chance of being in either group. The two treatment groups are 1) conventional preoperative imaging (X-ray, CT, and MRI) only 2) those that have had a 3D printed model created in addition to conventional imaging. There will be 40 patients in each group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. Both patient groups will undergo hip arthroscopy for treatment of their FAI.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: August 7, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)