Revision Total Knee Replacement Clinical Trial
Official title:
Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System
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?
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01156558 -
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
|
N/A |