3D Modeling to Improve Hip Arthroscopy Outcomes

NCT03995290 | Terminated

• 1 other identifier: Pro00086834
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

3D Hip Model from Pre-operative CT scan OTHER

A printed 3D model will be created based off of the patient's standard of care preoperative CT scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• The Hawkins Foundation: lead

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 24, 2019
• Study Start: November 1, 2020
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)