iTotal Pilot Study of ConforMIS Custom Total Knee Implant

Not Applicable

Completed

• Conditions: Knee Arthroplasty, Total

• Registration Number: NCT02186587
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Results First Submitted: 2016-04-14
• Results First Submitted QC: 2016-11-22
• Results First Posted: 2017-01-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• undergoing total knee arthroplasty

Exclusion Criteria

• BMI >40

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Distance Measured During 6-minute Walk Test	6 months	Subjects will walk for 6 minutes and the distance covered will be measured in feet.

Trial Locations

Locations (1)

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States