VISIONAIRE™ Value Study

Completed

Conditions studied: Osteoarthritis of the Knee

In brief

This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or investigational products, as all components are FDA approved and are commercially available.

Key facts

Study ID

NCT01107769

Run by

Smith & Nephew, Inc.

People needed

38

Starts

2010-04-01

Expected to finish

2011-02-01

Last updated by the study team

2011-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the inclusion criteria.
• Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
• Patient is of legal age to consent, and is skeletally mature.
• Patient is willing to sign and date an IRB/IEC approved consent form.

You may not qualify if…

• Patients must not meet any of the exclusion criteria.
• Patient has poor bone stock making a TKA unjustifiable.
• Patient has active, local infection or previous intra-articular infections.
• Patient has neuropathic (Charcot) joint.
• Patient is pregnant or may become pregnant during the course of the study.
• Patient is severely overweight (BMI >40).
• Patient is a prisoner.

Where it is running

• John Noble, Jr. — Lake Charles, Louisiana, United States

Full record on ClinicalTrials.gov

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