Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Nantes University Hospital
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- compare the functionality of the knee after installation of a total knee replacement between the 2 groups
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.
Investigators
Eligibility Criteria
Inclusion Criteria
- •all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
Exclusion Criteria
- •distorded axes or laxity requiring the establishment of constrained prosthesis
Outcomes
Primary Outcomes
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
Time Frame: 2 years after
The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.
Secondary Outcomes
- to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary(2 years after)
- medico-economic evaluation type "Cost minimization"(2 years after)