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)

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)

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications; Knee Arthropathy; Robotic Assisted Arthroplasty; TKA Outcomes
• Intervention / Treatment: Procedure: Robotic TKA; Procedure: Conventional TKA

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 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:

1. >= 18 Years Male or Female
2. With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
3. The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
4. Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.

Exclusion Criteria:

1. 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.
2. 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:

1. Accuracy and Reproducibility of Skywalker with eMP knee
2. Learning Curve of adopting Skywalker with eMP knees
3. Postop function recovery in eMP patients with Skywalker
4. Safety of eMP knee with Skywalker based on intra-op and postop complications
5. (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

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theofilos Karachalios, MD, PhD, Professor; Phone Number: +302413501199; Email: kar@med.uth.gr
• Study Contact Backup: Name: Georgios Komnos, MD, PhD; Phone Number: +302413501199; Email: gekomnos@hotmail.com

Study Locations

• Greece
  • Thessaly
    • Larisa, Thessaly, Greece, 41334
      • Recruiting
      • University Hospital of Larisa
      • Contact: Theofilos Karachalios, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. >= 18 Years Male or Female
2. With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
3. The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
4. Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.

Exclusion Criteria:

1. 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.
2. Concurrent participation in any other total hip or knee replacement studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic-assisted Skywalker device - Evolution Medial Pivot	Procedure: Robotic TKA; Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
Active Comparator: Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of implantation measured in degrees of correction	Accuracy based on planned vs actual size and alignment parameters	1 year after intervention
Learning curve	Learning curve based on surgical time	1 year after intervention

Collaborators and Investigators

• Sponsor: Orthopaedic Department of General University Hospital of Laria
• Collaborators: MicroPort Orthopedics Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: May 8, 2025
• First Posted (Actual): May 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: knee arthroplasty; Skywalker robotic System; evolution medial pivot implant
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 50377/24-11-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No