Real Time 3D Imaging and Surrogate Bone Model

Arthritis Clinical Trial

Official title: Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial

Status Recruiting

Clinical Trial Summary

This is an observer-blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have consented to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This treatment is standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. The only difference in treatment between the groups will be the use of a surrogate bone model to help assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic testing performed specifically related to this study consists of obtaining one pre-operative and one post-operative CT scan. The post-operative scan is to be performed within two weeks of surgery.

The investigators predict that those patients with 3D imaging and bone model will have better acetabular shell placement than those with standard preoperative planning.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

• NCT number: NCT02204007
• Study type: Interventional
• Source: The Cleveland Clinic
• Contact: Alison Klika, MS
• Phone: (216) 444-4954
• Email: klikaa@ccf.org
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Completion date: April 2015