Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505020
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-06
First Post:
2020-04-30
Brief Title:
The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 surgeons understanding of each patients 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 risksbenefitsalternatives 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
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 risksbenefitsalternatives 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None