Outcomes of Robotic Total Hip Arthroplasty

Withdrawn

• Conditions: Osteoarthritis

• Registration Number: NCT01672320
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Study Start: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States