Outcomes of Robotic Total Hip Arthroplasty
This study is not yet open for participant recruitment.
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
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: August 21, 2012
Last verified: August 2012
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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 |
|---|
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Osteoarthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study |
Resource links provided by NLM:
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
| Estimated Enrollment: | 1000 |
| 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 |
|---|
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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
|
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672320
Contacts
| Contact: Charles Bragdon, PhD | 617-724-7544 | cbragdon@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Charles Bragdon, PhD 617-724-7544 cbragdon@partners.org | |
| Principal Investigator: Charles Bragdon, PhD | |
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: | August 21, 2012 |
| 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 May 23, 2013