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NCT Number: NCT06969222

l Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)

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)

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larisa

Larissa, Thessaly, 41334, Greece

Location status: Recruiting

Location contact

Theofilos Karachalios, MD,PhD

CONTACT

About this study

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 surgeon. The learning curve cases will be determined based on the assessment of parameters such as surgical time etc.

Patients who have received eMP knees with conventional instrumentations or non-MP TKAs (retrospective)

Inclusion criteria

  • >= 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 criteria

  • 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.

Study Objectives: Evaluate Safety and Performance of RA-TKA with Skywalker and eMP knee and address research questions include but not limited to:

  • Accuracy and Reproducibility of Skywalker with eMP knee
  • Learning Curve of adopting Skywalker with eMP knees
  • Postop function recovery in eMP patients with Skywalker
  • Safety of eMP knee with Skywalker based on intra-op and postop complications
  • (Enhanced) Kinematics of eMP with Skywalker compared to manual and other non MP TKA

Study Endpoints Primary Effectiveness Endpoints

  • FJS and OKS at 12 months
  • Kinematics from RSA at min 6 months

Primary Safety Endpoint

  • Revisions / surgical interventions including MUA on the index knee due to any reasons
  • Serious Adverse Events that require hospitalization

Secondary Endpoint

  • Accuracy based on planned vs actual size and alignment parameters
  • FJS at 6 weeks, 3 months, 6 months
  • OKS at 6 weeks, 3 months, 6 months
  • ROM from KSS at 6 weeks, 6 months and 12 months
  • Learning Curve based on surgical time

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 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 criteria

  • 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.

Treatment and study plan

Robotic TKA

Procedure

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

Conventional TKA

Procedure

Total knee replacement of arthritic knees performed manually

Primary outcomes

  1. Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

    Time frame: 2 years after intervention

    KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months

  2. Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

    Time frame: 2 years after intervention

    FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months

  3. Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

    Time frame: 2 years after intervention

    VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months

  4. Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

    Time frame: 2 years after intervention

    OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months

  5. Primary safety endpoints

    Time frame: 1 year after intervention

    Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects

Secondary outcomes

  1. Accuracy of implantation measured in degrees of correction

    Time frame: 1 year after intervention

    Accuracy based on planned vs actual size and alignment parameters

  2. Learning curve

    Time frame: 1 year after intervention

    Learning curve based on surgical time

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Komnos, MD, PhD

CONTACT

[email protected]

+302413501199

Theofilos Karachalios, MD, PhD, Professor

CONTACT

[email protected]

+302413501199

Sponsors and collaborators

Lead sponsor

Orthopaedic Department of General University Hospital of Laria

Other

Collaborators

  • MicroPort Orthopedics Inc.

Registry information

Official study title

A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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