Osteoarthritis Clinical Trial
Official title:
Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
Total knee arthroplasty represents over 70 000 surgical procedures per year in France,
increasing about 10% each year since the early 1990s. Clinical experience shows a strong
rate of success on pain relieve and improvement of knee articular function for these
patients.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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