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

Orthopaedic Department of General University Hospital of Laria

Status: Enrolling

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

Treatments: Procedure: Conventional TKA; Procedure: Robotic TKA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06969222

50377/24-11-22

Details and patient eligibility

About

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)

Full 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

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Robotic-assisted Skywalker device - Evolution Medial Pivot

Active Comparator group

Treatment:

Procedure: Robotic TKA

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

Active Comparator group