Outcomes of Robotic Total Hip Arthroplasty

Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study

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 Overview

• Status: Withdrawn
• Conditions: Osteoarthritis

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults requiring a total hip arthroplasty procedure.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Phase II; An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients
Phase I; An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: MAKO Surgical Corp.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Arthroplasty; Outcomes; Robotic; Total Hip Arthroplasty; Cup Positioning
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2012P000809