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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)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06969222
Enrollment
122
Registered
2025-05-13
Start date
2023-09-05
Completion date
2026-12-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

knee arthroplasty, Skywalker robotic System, evolution medial pivot implant

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)

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

Interventions

PROCEDURERobotic TKA

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

Total knee replacement of arthritic knees performed manually

Sponsors

MicroPort Orthopedics Inc.
CollaboratorINDUSTRY
Orthopaedic Department of General University Hospital of Laria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints2 years after interventionKOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Primary safety endpoints1 year after interventionRevisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects

Secondary

MeasureTime frameDescription
Learning curve1 year after interventionLearning curve based on surgical time
Accuracy of implantation measured in degrees of correction1 year after interventionAccuracy based on planned vs actual size and alignment parameters

Countries

Greece

Contacts

Primary ContactTheofilos Karachalios, MD, PhD, Professor
kar@med.uth.gr+302413501199
Backup ContactGeorgios Komnos, MD, PhD
gekomnos@hotmail.com+302413501199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026