3D Modeling to Improve Hip Arthroscopy Outcomes
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|ClinicalTrials.gov Identifier: NCT03995290|
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment|
|Femoroacetabular Impingement||Other: 3D Hip Model from Pre-operative CT scan|
Following a standard of care pre-operative CT scan, a 3D rendering of the CT scan will be completed. The de-identified CT Scan data will be transferred to the Clemson University Bioengineering Department, and a 3D modeling software will convert it to a computer model that will then be 3D printed. During the doctor-patient pre-operative consultation, the 3D Printed model will be used to assist the doctor in describing the patient's pathology and upcoming surgical procedure. In this pilot study, the surgeon will make measurements and estimates of resection for the femoroplasty and acetabuloplasty off of 2D CT scan, MRI, and x-rays. This will then be compared quantitatively to the results of the 3D model/3D printing measurements. Surgeon debriefings will occur postoperatively to determine the benefit of the model and how well it matched up to what the surgeon experienced during the surgery.
FAI involves complex anatomic morphology which can be unique to each patient. A thorough understanding of the type and specifically location of impingement is paramount to successful results if surgery is required. 2D imaging has limitations when analyzing a 3D anatomic lesion. 3D printed hip models have the potential to provide superior preoperative planning and subsequent surgical results. In addition, 3D models can potentially improve patient understanding, expectations, and outcomes.
|Study Type :||Observational|
|Estimated Enrollment :||5 participants|
|Official Title:||The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
- Other: 3D Hip Model from Pre-operative CT scan
A printed 3D model will be created based off of the patient's standard of care preoperative CT scan.
- Resection Measurement Variations [ Time Frame: Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations. ]The surgeon will make estimates of resection for the femoroplasty and acetabuloplasty based on standard pre-operative imaging (in millimeters). The surgeon will also make estimates based on the 3D model/3D printing measurements. Actual resection measurements will be collected intra-operatively and compared to the surgeon's pre-operative predictions based on the 3D model and the standard imaging techniques (in millimeters).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995290
|Contact: Kyle Adams, BS||864-454-7458||Kyle.Adams@hawkinsfoundation.com|
|United States, South Carolina|
|Steadman Hawkins Clinic of the Carolinas - Greenville Health System||Recruiting|
|Greenville, South Carolina, United States, 29615|
|Contact: Kyle Adams, BS 864-454-7458 firstname.lastname@example.org|
|Sub-Investigator: Jason Folk, MD|
|Principal Investigator: John DesJardins, PhD|
|Sub-Investigator: Robert Longstaffe, MD|
|Sub-Investigator: Zachary Sutton, MS, MSPAS, PA-C|