To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant. Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).
The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
Missouri Orthopaedic Institute
Columbia, Missouri, United States
Distance Measured During 6-minute Walk Test
Subjects will walk for 6 minutes and the distance covered will be measured in feet.
Time frame: 6 months
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