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A Comparative Study of Knee Systems

NCT01331278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-04-08

No results posted yet for this study

Summary

The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.

Conditions

  • Osteoarthritis of the Knee

Interventions

PROCEDURE

Total Knee Arthroplasty with Custom Cutting Blocks

Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant

PROCEDURE

Total Knee Arthroplasty via Computer Assisted Surgery

Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant

Sponsors & Collaborators

  • Foundation for Southwest Orthopedic Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-08-31
Completion
2011-03-31

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 NCT01331278 on ClinicalTrials.gov