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)
>= 18 Years Male or Female
With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
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.
Concurrent participation in any other total hip or knee replacement studies.
Parallel
Robotic TKA
Procedure/SurgeryTotal knee replacement of arthritic knees either with robotic-assisted Skywalker device
Conventional TKA
Procedure/SurgeryTotal knee replacement of arthritic knees performed manually
Primary 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
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
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
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
Accuracy of implantation measured in degrees of correction
Accuracy based on planned vs actual size and alignment parameters
Learning curve
Learning curve based on surgical time
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Orthopaedic Department of General University Hospital of Laria
Lead sponsor
MicroPort Orthopedics Inc.
Collaborator
