Status:
WITHDRAWN
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex
Lead Sponsor:
Exactech
Conditions:
Arthropathy of Knee
Arthritis and/or Post-traumatic Degenerative Problems
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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™ ("Optetr...
Detailed Description
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™ ("Optetr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00808613
Start Date
December 1 2008
End Date
January 1 2012
Last Update
September 1 2022
Active Locations (1)
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1
Hampton Roads Orthopedics
Newport News, Virginia, United States, 23606