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. (My Knee)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: the prosthesis GMK ® without the ancillary MyKnee ® LBS
* Device: Matched patient cutting blocks MyKnee ® LBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. | Device: the prosthesis GMK ® without the ancillary MyKnee ® LBS<br> <br> |
| Other: Matched patient<br>The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS. | Device: Matched patient cutting blocks MyKnee ® LBS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the functionality of the knee after installation of a total knee replacement between the 2 groups | 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. | 2 years after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Compare the costs of implementing the two strategies (A and B) taking into account the resources consumed (operative time, anesthetic drugs, blood bags ...). Determine the least costly therapeutic intervention and medico-economic impact in the current system of financing of hospital expenditure. | 2 years after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis