Outcomes of Robotic Total Hip Arthroplasty

Massachusetts General Hospital

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Survivorship of Components

Defined as implant remaining in subject.

Time frame: 10 Years

Adverse Events

Protocol deviations, complications, "lost to follow-up"

Time frame: 10 Years

Secondary Outcomes

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.

Time frame: Up to 10 Years

Data from ClinicalTrials.gov

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