This is a prospective trial that attempts to develop evidence on the safety and performance of RA-TKA (Robotic-assisted total knee arthroplasty) with Skywalker and eMP (Evolution Medial Pivot) knee. Moreover to evaluate performance of eMP patients with Skywalker (in comparison to eMP with conventional instrumentations and non-MP TKAs)
The included patients will be those who meet study inclusion and exclusion criteria (IEC) to receive RA-TKA with Skywalker and eMP knees. This cohort will include learning curve cases from each surgeon. The learning curve cases will be determined based on the assessment of parameters such as surgical time etc. Patients who have received eMP knees with conventional instrumentations or non-MP TKAs (retrospective) Inclusion Criteria: 1. \>= 18 Years Male or Female 2. With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity 3. The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment 4. Must be independent, ambulatory, and can comply with all post-operative evaluations and visits. Exclusion Criteria: 1. Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators. 2. Concurrent participation in any other total hip or knee replacement studies. Study Objectives: Evaluate Safety and Performance of RA-TKA with Skywalker and eMP knee and address research questions include but not limited to: 1. Accuracy and Reproducibility of Skywalker with eMP knee 2. Learning Curve of adopting Skywalker with eMP knees 3. Postop function recovery in eMP patients with Skywalker 4. Safety of eMP knee with Skywalker based on intra-op and postop complications 5. (Enhanced) Kinematics of eMP with Skywalker compared to manual and other non MP TKA Study Endpoints Primary Effectiveness Endpoints * FJS and OKS at 12 months * Kinematics from RSA at min 6 months Primary Safety Endpoint * Revisions / surgical interventions including MUA on the index knee due to any reasons * Serious Adverse Events that require hospitalization Secondary Endpoint * Accuracy based on planned vs actual size and alignment parameters * FJS at 6 weeks, 3 months, 6 months * OKS at 6 weeks, 3 months, 6 months * ROM from KSS at 6 weeks, 6 months and 12 months * Learning Curve based on surgical time
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
122
Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
Total knee replacement of arthritic knees performed manually
University Hospital of Larisa
Larissa, Thessaly, Greece
RECRUITINGPrimary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Time frame: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months
Time frame: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months
Time frame: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Time frame: 2 years after intervention
Primary safety endpoints
Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects
Time frame: 1 year after intervention
Accuracy of implantation measured in degrees of correction
Accuracy based on planned vs actual size and alignment parameters
Time frame: 1 year after intervention
Learning curve
Learning curve based on surgical time
Time frame: 1 year after intervention
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