Clinical trial NCT06969222: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Arthroplasty Complications
Robotic Assisted Arthroplasty
TKA Outcomes
Keywords: knee arthroplasty
Skywalker robotic System
evolution medial pivot implant
Lead sponsor: Orthopaedic Department of General University Hospital of Laria
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2025-05-13
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
timeFrame: 2 years after intervention
measure: Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
timeFrame: 2 years after intervention
measure: Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
timeFrame: 2 years after intervention
measure: Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
timeFrame: 2 years after intervention
measure: Primary safety endpoints
timeFrame: 1 year after intervention
Secondary outcomes:
measure: Accuracy of implantation measured in degrees of correction
timeFrame: 1 year after intervention
measure: Learning curve
timeFrame: 1 year after intervention
Other outcomes:
Locations:
city: Larisa
country: Greece
facility: University Hospital of Larisa
state: Thessaly
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.