NCT02186587

iTotal Pilot Study of ConforMIS Custom Total Knee Implant

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Knee Arthroplasty, Total

Interventions

Type	Name	Description
DEVICE	ConforMIS custom total knee	Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-06-01
• Completion: 2016-04-01
• First posted: 2014-07-10
• Last updated: 2023-05-23
• Results posted: 2017-01-19

Locations

1 site across 1 country: United States