iTotal Pilot Study of ConforMIS Custom Total Knee Implant
NCT ID: NCT02186587
Last Updated: 2023-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2014-06-30
2016-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ConforMIS
Subjects who receive a ConforMIS custom total knee implant.
ConforMIS custom total knee
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
Interventions
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ConforMIS custom total knee
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Principal Investigators
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Sonny Bal, MD
Role: PRINCIPAL_INVESTIGATOR
Professor - PI
Locations
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Missouri Orthopaedic Institute
Columbia, Missouri, United States
Countries
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Other Identifiers
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1206872
Identifier Type: -
Identifier Source: org_study_id
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