A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: t
View:
• \>= 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.
Locations
Other Locations
Greece
University Hospital of Larisa
RECRUITING
Larissa
Contact Information
Primary
Theofilos Karachalios, MD, PhD, Professor
kar@med.uth.gr
+302413501199
Backup
Georgios Komnos, MD, PhD
gekomnos@hotmail.com
+302413501199
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 122
Treatments
Active_comparator: Robotic-assisted Skywalker device - Evolution Medial Pivot
Active_comparator: Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot
Related Therapeutic Areas
Sponsors
Leads: Orthopaedic Department of General University Hospital of Laria
Collaborators: MicroPort Orthopedics Inc.