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.
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. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Optetrak Posterior Stabilized total knee replacement
Optetrak Hi-Flex total knee replacement
Hampton Roads Orthopedics
Newport News, Virginia, United States
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
Physician assess range of motion in knee joint
Time frame: 2 years
Knee Society Score (KSS)
Validated physician assessed outcome
Time frame: 2 years
Hospital for Special Surgery (HSS) Knee Score
Validated physician assessed outcome
Time frame: 2 years
Patient Satisfaction
Visual Analog Scale (1-10) where 10 is best.
Time frame: 2 years
Implant survivorship
Implant survivorship
Time frame: 2 years
Radiographic evaluation
Radiographic analysis
Time frame: 2 years
Complications
Adverse Events
Time frame: 2 years
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