Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
NCT ID: NCT01814384
Last Updated: 2015-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2013-03-31
2016-09-30
Brief Summary
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Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control group
Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
prosthesis GMK ® without the ancillary MyKnee ® LBS
Matched patient
Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Matched patient cutting blocks MyKnee ® LBS
Interventions
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prosthesis GMK ® without the ancillary MyKnee ® LBS
Matched patient cutting blocks MyKnee ® LBS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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University Hospital of Nantes
Nantes, France, France
Countries
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Other Identifiers
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RC 12_0100
Identifier Type: -
Identifier Source: org_study_id
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