University Hospital of Larisa
Larissa, Thessaly, 41334, Greece
Location status: Recruiting
Location contact
Theofilos Karachalios, MD,PhD
CONTACT
NCT Number: NCT06969222
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)
Interested in participating?
Request Info18 year–95 year
All sexes
Interventional
Not applicable
Larissa, Thessaly, 41334, Greece
Location status: Recruiting
Theofilos Karachalios, MD,PhD
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
Total knee replacement of arthritic knees performed manually
Time frame: 2 years after intervention
KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Time frame: 2 years after intervention
FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months
Time frame: 2 years after intervention
VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months
Time frame: 2 years after intervention
OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Time frame: 1 year after intervention
Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects
Time frame: 1 year after intervention
Accuracy based on planned vs actual size and alignment parameters
Time frame: 1 year after intervention
Learning curve based on surgical time
Contact information is provided by the study sponsor or research team.
Georgios Komnos, MD, PhD
CONTACT
Theofilos Karachalios, MD, PhD, Professor
CONTACT
Orthopaedic Department of General University Hospital of Laria
Other
A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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