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Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest among surgeons to quantify the effectiveness of specific implant designs, the goal of the current project is to use Radiostereometric Analysis (RSA) to provide conclusive and clinically relevant results on fixation of the tibial component with the DePuy M.B.T. Revision TKA system using Metaphyseal Sleeves.
Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term fixation at the bone-implant interface.
• Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does exceed 0.2 mm indicating inadequate long-term fixation at the bone-implant interface.
b) In what proportion of patients is adequate fixation achieved?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBT Revision Component |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant Migration | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| BMD | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Health outcome questionnaire | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Failed primary TKR
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dunbar | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital District Health Authority | Halifax | Nova Scotia | B3H 3A7 | Canada |
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