knee prostheses osteoarthritis
Conditions
Interventions
The intervention concerns the use of the OrthoSensor by the surgeon during TKA.
*OrthoSensor* VERASENSE** has recently be introduced by Biomet. It is a trial
bearing designed for use with the Vangu
Sponsors
Atrium Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients diagnosed with osteoarthritis and indicated for TKA - Patients treated prospectively with the Vanguard Total Knee System - Patients providing informed consent
Exclusion criteria
Exclusion criteria: - Age > 75 yrs - BMI > 35 - Extreme varus valgus - Patients who had a TKA on contra lateral side within the last 1 year - Patients who will need lower limb joint replacement for another joint within one year - Patients who require revision of previously implanted TKA - Poor medical condition (e.g. patients with malignancy) - Cognitive problems - Language problems - Patients diagnosed with rheumatoid arthritis, posttraumatic arthritis - Not being eligible for being included due to any other medical conditions as decided by the ortopaedic surgeons of the Atrium MC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is determined based on the main research question, which is *to assess patient outcome in TKA cases with OrthoSensor in comparison to TKA cases without using OrthoSensor*. Patient outcomes in this study include X-ray assessment, patient satisfaction, pain and function as measured by PROMS and objective outcomes as measured by sensor technologies (IMA and AM). The parameters produced by IMA and AM output are considered the most relevant outcome parameters, because they are objective, not dominated by pain and have previously been indicated as having high discriminative and diagnostic power to differentiate patients with end stage osteoarthritis from healthy subjects (23,24). From the sensor parameters, the walking speed is the most relevant. Recent studies showed that the walking speed is a powerful parameters as walking speed has the highest discriminative power in differentiating subjects with knee limitations from healthy subjects (23). In addition walking speed has previously been associated with general health and well being (19-22). Since the step frequency is 1) highly related to the walking speed, 2) easier to derive from IMA as it does not require the exact walked distance to be calculated (in contrast to walking speed) and 3) also derived from AM measurements, the step frequency is used as most important and clinically relevant outcome measure. The main study parameter used in this study is the step frequency. Moreover the power calculation of this study is based on previous results using the step frequency as variable. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceived function, measured using KOOS-PS, New-KSS, FJS 2. Patient satisfaction measured using New-KSS 3. Pain measured usingNew-KSS 4. objectively measurde function: IMA Gait test (Step length, Step time asymmetry, Step time variability, Pelvic obliquity), IMA Sit-stand test ( Bending angle), IMA Block step test (Asymmetry pelvic obliquity). 5. physical activity measured with AM: Quantity (# steps, # transfers, # walking bouts, # stair climbing events), duration ( Duration walking, Duration sitting, duration standing, Duration high intense activities), quality (Intensity of activities, Distribution of walking bouts, Distribution of sitting events) 6. Prevalence of radiolucency, Location of radiolucency, Osteolysis as measured on X ray | — |
Countries
Netherlands
Outcome results
None listed