Osteoarthritis Clinical Trial
Official title:
Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.
The primary objective of this investigation is to compare the precision of long leg
alignment achieved by the two types of procedure. The secondary objectives of this
investigation are to:
Compare the accuracy of long leg alignment achieved by the two types of procedure.
Compare the number of optimal implantations achieved by the two types of procedure.
Compare the clinical performance of the knee replacement in subjects who have undergone one
of the two types of procedure.
Compare the functional outcome achieved by subjects who have undergone one of the two types
of procedure.
Compare the interface radiographic appearance 5 years post-operatively between the two types
of procedure.
Compare the accuracy and precision of long leg alignment achieved by the two types of
procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy
and precision between the final follow-up and baseline.
Compare the Adverse Events experienced by the subjects who have undergone the two types of
procedure.
Primary endpoint: to compare the precision of the long leg alignment of the Ci MiTKA vs. the
non navigated conventional TKA, specifically 3 months to demonstrate the variability of the
mechanical axis.
Secondary endpoints: to compare the precision of the long leg alignment of the Ci MiTKA vs.
the non navigated conventional TKA specifically to demonstrate the proportion of procedures
that fall within a satisfactory alignment window in either group.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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