Outcomes of Robotic Total Hip Arthroplasty

This study has been withdrawn prior to enrollment.
(No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.)
Sponsor:
Collaborator:
MAKO Surgical Corp.
Information provided by (Responsible Party):
Charles R. Bragdon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01672320
First received: August 10, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Survivorship of Components [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Defined as implant remaining in subject.

  • Adverse Events [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
    Protocol deviations, complications, "lost to follow-up"


Secondary Outcome Measures:
  • Retrieval Analysis of implants from revision surgery [ Time Frame: Up to 10 Years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Assessment/questionaire HOOS [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    Hip Disability and Osteoarthritis Outcome

  • Assessment/Questionaire UCLA Activty Score [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    Assesses level of activity

  • Assessment/Questionaire EQ-5D [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    General health and cost effective analysis

  • Assessment/questionaire [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    Hip desease specific questionaire

  • Assessment/Questionaire Case Mix Indicator [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    Identifies comorbidities


Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults requiring a total hip arthroplasty procedure.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672320

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
MAKO Surgical Corp.
  More Information

No publications provided

Responsible Party: Charles R. Bragdon, Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01672320     History of Changes
Other Study ID Numbers: 2012P000809
Study First Received: August 10, 2012
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Robotic
Arthroplasty
Total Hip Arthroplasty
Cup Positioning
Outcomes

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014