3D Modeling to Improve Hip Arthroscopy Outcomes

Femoroacetabular Impingement Clinical Trial

Official title:

The Use of Patient-Specific 3D Printed Anatomic Models in Pre-Operative Planning and Patient Engagement to Improve Hip Arthroscopy Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03995290
• Other study ID #: Pro00086834
• Status: Terminated
• Start date: November 1, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: September 2021
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

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.

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas - Greenville Health System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection Measurement Variations	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).	Pre-operative through date of surgery: Resection measurements will be collected intra-operatively and compared to the pre-operative estimations.