Arthritis and/or Post-traumatic Degenerative Problems, Arthropathy of Knee
Conditions
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™ (Optetrak® HF, Exactech, Gainesville, FL) knee designs.
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™ (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.
Interventions
DEVICEOptetrak PS
Optetrak Posterior Stabilized total knee replacement
DEVICEOptetrak Hi-Flex
Optetrak Hi-Flex total knee replacement
Sponsors
Exactech
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is indicated for total knee replacement with a posterior stabilized device. 2. Patient is between the ages of 50 and 80 years old 3. Patient has a Body Mass Index (BMI) \< 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 4. Patient is skeletally mature. 5. 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. 6. Patient is willing and able to review and sign a study Informed Consent.
Exclusion criteria
1. Patient has a Body Mass Index (BMI) \> 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 2. Patient is skeletally mature 3. 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. 4. Patient is willing and able to review and sign a study Informed Consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion. | 2 years | Physician assess range of motion in knee joint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital for Special Surgery (HSS) Knee Score | 2 years | Validated physician assessed outcome |
| Patient Satisfaction | 2 years | Visual Analog Scale (1-10) where 10 is best. |
| Knee Society Score (KSS) | 2 years | Validated physician assessed outcome |
| Radiographic evaluation | 2 years | Radiographic analysis |
| Complications | 2 years | Adverse Events |
| Implant survivorship | 2 years | Implant survivorship |
Countries
United States
Outcome results
None listed