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NCT02186587 Clinical Trial

iTotal Pilot Study of ConforMIS Custom Total Knee Implant

Knee Arthroplasty, Total Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02186587
Other study ID # 1206872
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date April 2016

Study information
Verified date April 2023
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date April 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - undergoing total knee arthroplasty Exclusion Criteria: - BMI >40

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ConforMIS custom total knee
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months

Locations
Country Name City State
United States Missouri Orthopaedic Institute Columbia Missouri

Sponsors (1)
Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distance Measured During 6-minute Walk Test Subjects will walk for 6 minutes and the distance covered will be measured in feet. 6 months
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