Outcomes of Robotic Total Hip Arthroplasty
|ClinicalTrials.gov Identifier: NCT01672320|
Recruitment Status : Withdrawn (No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.)
First Posted : August 24, 2012
Last Update Posted : November 5, 2013
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients
An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.
- Survivorship of Components [ Time Frame: 10 Years ]Defined as implant remaining in subject.
- Adverse Events [ Time Frame: 10 Years ]Protocol deviations, complications, "lost to follow-up"
- Retrieval Analysis of implants from revision surgery [ Time Frame: 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.
- Assessment/questionaire HOOS [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]Hip Disability and Osteoarthritis Outcome
- Assessment/Questionaire UCLA Activty Score [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]Assesses level of activity
- Assessment/Questionaire EQ-5D [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]General health and cost effective analysis
- Assessment/questionaire [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]Hip desease specific questionaire
- Assessment/Questionaire Case Mix Indicator [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]Identifies comorbidities
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672320
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|