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A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides

NCT01072019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-06-27

No results posted yet for this study

Summary

The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:

1. Standard knee cutting guides;
2. MRI generated patient specific custom cutting guides.

Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.

Conditions

  • Osteoarthritis of the Knee

Interventions

OTHER

Instrument

Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Ryan M Nunley, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT01072019 on ClinicalTrials.gov