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3D Modeling to Improve Hip Arthroscopy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03995290
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : April 10, 2020
Information provided by (Responsible Party):
The Hawkins Foundation

Brief Summary:
This study will pilot the use of 3D printed models of the hip, for use in pre-operative planning and patient communication to improve clinical outcomes and patient engagement. This method will be implemented in the setting of femoroacetabular impingement (FAI), with the goal of identifying and measuring specific anatomical pathologies and impingement (range of motion) risks, to communicate a pre-operative plan to both the surgical team, and the patient.

Condition or disease Intervention/treatment
Femoroacetabular Impingement Other: 3D Hip Model from Pre-operative CT scan

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The subject will be approached for participation in this study after the subject has made the decision to undergo a hip arthroscopy procedure and will be receiving a standard of care hip CT Scan. Patients who meet all criteria will be offered enrollment into the study.

Inclusion Criteria:

  • Surgical candidate for a hip arthroscopy for the treatment of femoroacetabular impingement
  • Subject is willing to sign the informed consent.
  • Subject is at least 18 years of age.

Exclusion Criteria (n/a)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03995290

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Contact: Kyle Adams, BS 864-454-7458

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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   
Sub-Investigator: Jason Folk, MD         
Principal Investigator: John DesJardins, PhD         
Sub-Investigator: Robert Longstaffe, MD         
Sub-Investigator: Zachary Sutton, MS, MSPAS, PA-C         
Sponsors and Collaborators
The Hawkins Foundation
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Responsible Party: The Hawkins Foundation Identifier: NCT03995290    
Other Study ID Numbers: Pro00086834
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes