Status:
UNKNOWN
Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Medacta USA
Conditions:
Knee Arthropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use. A foreseeable increase in the number of surgeries in the future,...
Detailed Description
After validation of the inclusion criteria, the surgeon will perform the randomization (1:1): single-use ancillary group or conventional ancillary group. Only the medical team and the block staff will...
Eligibility Criteria
Inclusion
- Patient with gonarthrosis or inflammatory arthrosis of the knee leading to surgical indication for total knee arthroplasty
- Informed patient, able to understand the information, not opposing to participate this protocol
- patient affiliate to social security
Exclusion
- Extra-joint Deformation needing bone associated gesture
- Preoperative active or suspected infection
- Local evolutive tumoral pathology
- Medical history with bone gesture on concerned knee
- Patient unable or refusing to give his consentement
- Pregnant woman or in age to be pregnant without use any effective contraceptive method
- Patient under maintenance of justice, tutelage or legal guardianship)
- Presence of any family, sociological, political or geographic situation able to interfere with the protocol
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04300439
Start Date
March 1 2020
End Date
March 1 2023
Last Update
March 9 2020
Active Locations (1)
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1
CHU de Nantes (University Hospital of Nantes)
Nantes, France