Outcomes of Robotic Total Hip Arthroplasty



Status:Not yet recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:20 - 75
Updated:11/23/2013
Start Date:January 2013
End Date:January 2023
Contact:Charles Bragdon, PhD
Email:cbragdon@partners.org
Phone:617-724-7544

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Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study


The objectives of this study are to evaluate the clinical value of robotic-assisted total
hip arthroplasty with respect to acetabular cup implantation, and to document the long-term
clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be
obtained at every study site to evaluate the basic clinical outcomes and post-operative
component placement accuracy of each MAKO® THA patient.

The hypothesis is that robotic preparation of the acetabulum will significantly reduce the
variability and inaccuracy in the component alignment parameters that lead to post-operative
complications, including implant failure.


Inclusion Criteria:

- Male or female

- 20 to 75 years of age

- Subjects requiring primary total hip replacement

- Contralateral hip should be relatively free from arthritis for comparison purposes,
specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.

- Subjects diagnosed with osteoarthritis or traumatic arthritis

- Subjects with avascular necrosis

- Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

- Subjects with difficulty understanding protocol for any reason

- Subjects with a limited life span

- Subjects with inflammatory hip disease, previous joint infection, or those requiring
hip revision surgery

- Female subjects who are pregnant, or who plan to get pregnant while enrolled in the
study
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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