Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Massachusetts General Hospital
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Charles R. Bragdon
Research Scientist
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 10 Years
Protocol deviations, complications, "lost to follow-up"
Survivorship of Components
Time Frame: 10 Years
Defined as implant remaining in subject.
Secondary Outcomes
- Retrieval Analysis of implants from revision surgery(Up to 10 Years)