Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
5955 Veterans' Memorial Lane Room 2106, VMB
Halifax, Nova Scotia, Canada
Start Date
January 1, 2021
Primary Completion Date
June 30, 2025
Completion Date
June 30, 2027
Last Updated
February 17, 2025
80
ESTIMATED participants
3D Print + Conventional imaging
OTHER
Conventional imaging
OTHER
Lead Sponsor
Nova Scotia Health Authority
NCT03909139
NCT06500364
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03909178