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

Femoro Acetabular Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04505020
• Other study ID #: 3DPRINT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study, we investigate the use of 3D models during pre and intra-operative planning could improve the success of hip arthroscopy and reduce the incidence of revision cases. By adding an adjunct to the common suite of pre-operative imaging modalities (X-ray, MRI and CT), we can change the surgeon's understanding of each patient's individual morphology with a tactile physical model. This study will compare the success of hip arthroscopy in patients with or without 3D printed models (in addition to traditional pre-operative imaging).

This will be a single-center, blinded observer, randomized controlled trial of 80 patients performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Center in Halifax, Nova Scotia. Patients with cam-type FAI involved in the study will be approached by the surgeon, Dr. Ivan Wong, or a delegate regarding the study during a pre-operative visit. Following a detailed discussion of the risks/benefits/alternatives of this study, the patient will be provided with a copy of the informed consent to review, if they demonstrate an interest in the study. If the patient wishes to be enrolled in the study, the research team will obtain patient consent for the study according to the Division of Orthopaedic Surgery and Nova Scotia Health Authority (NSHA) institutional protocols.

In the pre-operative period, there will be no additional time requirements for the participant, except for the informed consent process for the study. Routine X-ray radiographs, as well as a pre-operative MRI and CT scan, will be obtained for all subjects undergoing FAI surgery. The participants will not be exposed to any additional radiation. Subjects will complete a structured clinical examination conducted by a sports medicine fellowship-trained orthopaedic consultant. The patient will also complete pre-operative questionnaires.

Patients that have consented to the study will be randomized into two groups with a 50% chance of being in either 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. All patient groups will undergo hip arthroscopy for the treatment of their FAI.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	5955 Veterans' Memorial Lane Room 2106, VMB	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of times conventional imaging and 3D prints are referenced intra-operatively.	Another secondary outcome is the number of times each of the following are referenced intra-operatively: X-Rays, MRI, MRA, CT, CT with 3D reconstruction and 3D model of patient's hip. Additionally the number of X-Ray images taken intra-operatively will be recorded.	During surgery only
Primary	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
Primary	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
Primary	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	Differences in post-operative patient reported outcomes: iHOT-33	The secondary outcome is the differences in post-operative patient reported outcomes for the international hip outcome tool (iHOT-33) when compared to a pre-operative baseline. (Scores for the International hip outcome tool range from 0-100 where higher values represent better outcomes)	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: NAHS	The secondary outcome is the differences in post-operative patient reported outcomes for the Non-arthritic Hip Score (NAHS) when compared to a pre-operative baseline. (Scores for the Non-arthritic Hip Score range from 0-80 where higher values represent better outcomes).	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: EQ5D	The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire (EQ-5D) when compared to a pre-operative baseline. (Scores for EQ-5D range from 1-5 in 5 categories where lower values represent better outcomes in each category).	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: EQ5D-VAS	The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire-Visual Analog Scale (EQ-5D-VAS) when compared to a pre-operative baseline. (Scores for EQ-5D-VAS range from 0-100 where higher values represent better outcomes).	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: VR-12	The secondary outcome is the differences in post-operative patient reported outcomes for the Veteran's RAND 12 Item Health Survey (VR-12) when compared to a pre-operative baseline. (Scores for VR-12 range from 0-100 where higher values represent better outcomes).	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: HOS-Usual Activities	The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for usual activities (HOS-UA) when compared to a pre-operative baseline. (Scores for HOS range from 0-68 where higher values represent better outcomes).	Change in outcomes 24 months post operatively compared to Pre-operatively
Secondary	Differences in post-operative patient reported outcomes: HOS-Sport	The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for sports (HOS-S) when compared to a pre-operative baseline. (Scores for HOS range from 0-30 where higher values represent better outcomes).	Change in outcomes 24 months post operatively compared to Pre-operatively