Outcomes of Robotic Total Hip Arthroplasty

Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01672320

Enrollment

Registered

2012-08-24

Start date

2013-01-31

Completion date

2023-01-31

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Robotic, Arthroplasty, Total Hip Arthroplasty, Cup Positioning, Outcomes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Retrieval Analysis of implants from revision surgery	Up to 10 Years	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.

Other

Measure	Time frame	Description
Assessment/questionaire	Pre-op, 1, 3, 5, 7, 10 years after surgery	Hip desease specific questionaire
Assessment/questionaire HOOS	Pre-op, 1, 3, 5, 7, 10 years after surgery	Hip Disability and Osteoarthritis Outcome
Assessment/Questionaire Case Mix Indicator	Pre-op, 1, 3, 5, 7, 10 years after surgery	Identifies comorbidities
Assessment/Questionaire UCLA Activty Score	Pre-op, 1, 3, 5, 7, 10 years after surgery	Assesses level of activity
Assessment/Questionaire EQ-5D	Pre-op, 1, 3, 5, 7, 10 years after surgery	General health and cost effective analysis

Countries

United States

Outcome results