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| Name | Class |
|---|---|
| MicroPort Orthopedics Inc. | INDUSTRY |
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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)
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:
Exclusion Criteria:
Study Objectives: Evaluate Safety and Performance of RA-TKA with Skywalker and eMP knee and address research questions include but not limited to:
Study Endpoints Primary Effectiveness Endpoints
Primary Safety Endpoint
Secondary Endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted Skywalker device - Evolution Medial Pivot | Active Comparator |
| |
| Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic TKA | Procedure | Total knee replacement of arthritic knees either with robotic-assisted Skywalker device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints | KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months | 2 years after intervention |
| Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints | FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months | 2 years after intervention |
| Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints | VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months | 2 years after intervention |
| Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints | OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months | 2 years after intervention |
| Primary safety endpoints | Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects | 1 year after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of implantation measured in degrees of correction | Accuracy based on planned vs actual size and alignment parameters | 1 year after intervention |
| Learning curve | Learning curve based on surgical time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theofilos Karachalios, MD, PhD, Professor | Contact | +302413501199 | kar@med.uth.gr | |
| Georgios Komnos, MD, PhD | Contact | +302413501199 | gekomnos@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larisa | Recruiting | Larissa | Thessaly | 41334 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27482016 | Background | 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. | |
| 34040804 | Background | 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. |
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prospective randomized trial with 122 patients divided into two groups One operated with robotic-assisted arthroplasty and other operated with conventional total knee arthroplasty
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| Conventional TKA | Procedure | Total knee replacement of arthritic knees performed manually |
| 1 year after intervention |
| 34040803 | Background | 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. |