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

Official title

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

Overview

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

• Procedure Robotic TKA
  Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
• Procedure Conventional TKA
  Total knee replacement of arthritic knees performed manually

Primary outcome measures

• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints [Time frame: 2 years after intervention]
• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints [Time frame: 2 years after intervention]
• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints [Time frame: 2 years after intervention]
• Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints [Time frame: 2 years after intervention]
• Primary safety endpoints [Time frame: 1 year after intervention]

Secondary outcome measures (2)

• Accuracy of implantation measured in degrees of correction [Time frame: 1 year after intervention]
• Learning curve [Time frame: 1 year after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Greece · 1 center

• University Hospital of Larisa — Larissa

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. PMID 27482016
• 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
• 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

Identifiers

NCT: NCT06969222 · 50377/24-11-22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗