Status:
RECRUITING
l Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
Lead Sponsor:
Orthopaedic Department of General University Hospital of Laria
Collaborating Sponsors:
MicroPort Orthopedics Inc.
Conditions:
Knee Arthropathy
Arthroplasty Complications
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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. M...
Detailed Description
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 surgeo...
Eligibility Criteria
Inclusion
- \>= 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
- 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.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06969222
Start Date
September 5 2023
End Date
December 31 2026
Last Update
May 13 2025
Active Locations (1)
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1
University Hospital of Larisa
Larissa, Thessaly, Greece, 41334