Outcomes of Robotic Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study

Conditions
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Osteoarthritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase II<br>An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients | |
| Phase I<br>An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of Components | Defined as implant remaining in subject. | 10 Years | 
| Adverse Events | Protocol deviations, complications, lost to follow-up | 10 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrieval Analysis of implants from revision surgery | When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision. | Up to 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic, Arthroplasty, Total Hip Arthroplasty, Cup Positioning, Outcomes