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

NCT06969222 | Recruiting

• 1 other identifier: 50377/24-11-22
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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. Moreover to evaluate performance of eMP patients with Skywalker (in comparison to eMP with conventional instrumentations and non-MP TKAs)

Conditions

Knee Arthropathy; Arthroplasty Complications; Robotic Assisted Arthroplasty; TKA Outcomes

Keywords

knee arthroplasty; Skywalker robotic System; evolution medial pivot implant

Outcome Measures

Primary Outcomes (5)

• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

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

  2 years after intervention

• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

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

  2 years after intervention

• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

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

  2 years after intervention

• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints

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

  2 years after intervention

• Primary safety endpoints

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

  1 year after intervention

Secondary Outcomes (2)

• Accuracy of implantation measured in degrees of correction

  1 year after intervention

• Learning curve

  1 year after intervention

Study Arms (2)

Robotic-assisted Skywalker device - Evolution Medial Pivot

ACTIVE COMPARATOR

Procedure: Robotic TKA

Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot

ACTIVE COMPARATOR

Interventions

Robotic TKA PROCEDURE

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

Robotic-assisted Skywalker device - Evolution Medial Pivot

Conventional TKA PROCEDURE

Total knee replacement of arthritic knees performed manually

Eligibility Criteria

• Age: 18 Years - 95 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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.

You may not qualify if:

• Concurrent participation in any other total hip or knee replacement studies.

Sponsors & Collaborators

• Orthopaedic Department of General University Hospital of Laria: lead
• MicroPort Orthopedics Inc.: collaborator

Study Sites (1)

University Hospital of Larisa

Larissa, Thessaly, 41334, Greece

RECRUITING

Related Publications (3)

• Karachalios T, Varitimidis S, Bargiotas K, Hantes M, Roidis N, Malizos KN. An 11- to 15-year clinical outcome study of the Advance Medial Pivot total knee arthroplasty: pivot knee arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1050-5. doi: 10.1302/0301-620X.98B8.36208.

  PMID: 27482016 BACKGROUND

• St Mart JP, Goh EL. The current state of robotics in total knee arthroplasty. EFORT Open Rev. 2021 Apr 1;6(4):270-279. doi: 10.1302/2058-5241.6.200052. eCollection 2021 Apr.

  PMID: 34040804 BACKGROUND

• Siddiqi A, Horan T, Molloy RM, Bloomfield MR, Patel PD, Piuzzi NS. A clinical review of robotic navigation in total knee arthroplasty: historical systems to modern design. EFORT Open Rev. 2021 Apr 1;6(4):252-269. doi: 10.1302/2058-5241.6.200071. eCollection 2021 Apr.

  PMID: 34040803 BACKGROUND

Central Study Contacts

Theofilos Karachalios, MD, PhD, Professor

CONTACT

+302413501199; kar@med.uth.gr

Georgios Komnos, MD, PhD

CONTACT

+302413501199; gekomnos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedics, Head of Orthopaedic Department, University Hospital of Larisa

Model Details: prospective randomized trial with 122 patients divided into two groups One operated with robotic-assisted arthroplasty and other operated with conventional total knee arthroplasty

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: May 13, 2025
• Study Start: September 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)