iTotal Pilot Study of ConforMIS Custom Total Knee Implant

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Knee Arthroplasty, Total

Clinical Trial Details

NCT number	NCT02186587
Study type	Interventional
Source	University of Missouri-Columbia
Contact
Status	Completed
Phase	N/A
Start date	June 2014
Completion date	April 2016

View Details

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