RecruitingNot ApplicableNCT06969222

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)


Sponsor

Orthopaedic Department of General University Hospital of Laria

Enrollment

122 participants

Start Date

Sep 5, 2023

Study Type

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

Min Age: 18 YearsMax Age: 95 Years

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

PROCEDURERobotic TKA

Total knee replacement of arthritic knees either with robotic-assisted Skywalker device

PROCEDUREConventional TKA

Total knee replacement of arthritic knees performed manually


Locations(1)

University Hospital of Larisa

Larissa, Thessaly, Greece

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NCT06969222