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Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide

NCT00837772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-04-06

No results posted yet for this study

Summary

Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Standard cutting guide for TKA

Use of the usual cutting guide for surgical replacement of a diseased knee

DEVICE

Otismed MRI generated cutting guide for TKA

Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee

Sponsors & Collaborators

  • Phoenix VA Health Care System

    lead FED

Principal Investigators

  • Harold G. Dossett, MD MBA · Carl T. Hayden VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837772 on ClinicalTrials.gov