Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Withdrawn before enrolling · Not applicable

Conditions studied: Arthropathy of Knee, Arthritis and/or Post-traumatic Degenerative Problems

In brief

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.

Key facts

Study ID

NCT00808613

Run by

Exactech

People needed

0

Starts

2008-12-01

Expected to finish

2012-01-01

Last updated by the study team

2022-09-01

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is indicated for total knee replacement with a posterior stabilized device.
• Patient is between the ages of 50 and 80 years old
• Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
• Patient is skeletally mature.
• Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
• Patient is willing and able to review and sign a study Informed Consent.

You may not qualify if…

• Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)
• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
• Patient is skeletally mature
• Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
• Patient is willing and able to review and sign a study Informed Consent.

Where it is running

• Hampton Roads Orthopedics — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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