iTotal Pilot Study of ConforMIS Custom Total Knee Implant
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
CT-navigated, Patient-specific Custom Total Knee Replacement Versus Standard Total Knee Replacement: Comparison With a Marker-less Gait Analysis System and Validated Outcome Scores
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).
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).
Inclusion Criteria:
- undergoing total knee arthroplasty
Exclusion Criteria:
- BMI >40
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