Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques

Washington University School of Medicine1 site in 1 country25 target enrollmentMarch 2010

ConditionsOsteoarthritis of the Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis of the Knee
Sponsor: Washington University School of Medicine
Enrollment: 25
Locations: 1
Primary Endpoint: Patient dissatisfaction following primary total knee replacement.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

Standard knee cutting guides;
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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

May 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 - 75
•Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
•Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
•Correction of varus or valgus.
•Willing to participate and return for follow-up study visits.

Exclusion Criteria

•Infection
•Osteomyelitis
•Uncooperative patient or patient with neurologic disorders who is incapable of following directions
•Osteoporosis
•Metabolic disorders which may impair bone formation
•Osteomalacia
•Distant foci of infections which may spread to the implant site
•Rapid joint destruction
•Marked bone loss or bone resorption apparent on roentgenogram
•Vascular insufficiency

Outcomes

Primary Outcomes

Patient dissatisfaction following primary total knee replacement.

Time Frame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.

Secondary Outcomes

Postoperative recovery time following primary total knee replacement.(Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.)