Status:
TERMINATED
Real Time 3D Imaging and Surrogate Bone Model
Lead Sponsor:
The Cleveland Clinic
Conditions:
Arthritis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 tot...
Detailed Description
The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental surgical group) into this randomized clinical trial. All subjects will have the standard of care indications...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02204007
Start Date
June 1 2014
End Date
January 1 2015
Last Update
March 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195