l Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
Orthopaedic Department of General University Hospital of Laria
122 participants
Sep 5, 2023
INTERVENTIONAL
Summary
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)
Eligibility
Inclusion Criteria4
- >= 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.
Exclusion Criteria2
- 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.
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Interventions
Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
Total knee replacement of arthritic knees performed manually
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06969222