Real Time 3D Imaging and Surrogate Bone Model
| Status: | Completed |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| End Date: | April 2015 |
| Contact: | Alison Klika, MS |
| Email: | klikaa@ccf.org |
| Phone: | (216) 444-4954 |
Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
1
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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