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Outcomes of Robotic Total Hip Arthroplasty

NCT ID: NCT01672320

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2023-01-31

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.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Robotic Arthroplasty Total Hip Arthroplasty Cup Positioning Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase II

An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients

No interventions assigned to this group

Phase I

An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.

No interventions assigned to this group

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MAKO Surgical Corp.

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Charles R. Bragdon

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P000809

Identifier Type: -

Identifier Source: org_study_id