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

NCT ID: NCT06969222

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2026-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic-assisted Skywalker device - Evolution Medial Pivot

Group Type: ACTIVE_COMPARATOR

Robotic TKA

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

Robotic TKA

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

Intervention Type: PROCEDURE

Conventional TKA

Total knee replacement of arthritic knees performed manually

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: collaborator

Orthopaedic Department of General University Hospital of Laria

OTHER

Sponsor Role: lead

Responsible Party

Theofilos Karachalios

Professor of Orthopaedics, Head of Orthopaedic Department, University Hospital of Larisa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Larisa

Larissa, Thessaly, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Theofilos Karachalios, MD, PhD, Professor

Role: CONTACT

kar@med.uth.gr

+302413501199

Georgios Komnos, MD, PhD

Role: CONTACT

gekomnos@hotmail.com

+302413501199

Facility Contacts

Theofilos Karachalios, MD,PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 27482016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34040804 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34040803 (View on PubMed)

Other Identifiers

50377/24-11-22

Identifier Type: -

Identifier Source: org_study_id