Real Time 3D Imaging and Surrogate Bone Model

Stopped early · Not applicable

Conditions studied: Arthritis

In brief

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.

Key facts

Study ID

NCT02204007

Run by

The Cleveland Clinic

People needed

36

Starts

2014-06-01

Expected to finish

2015-01-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
• Primary, unilateral Total hip arthroplasty (THA)
• 18 to 85 years old at time of surgery
• Able to get a pre- and post-operative CT scan at the Cleveland Clinic Main Campus at least 10 days prior to surgery

You may not qualify if…

• Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
• Pregnancy
• Incarceration
• Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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