Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

Study Overview
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Brief Summary
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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.

Official Title
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Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: 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>Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. | Device: prosthesis GMK ® without the ancillary MyKnee ® LBS<br> <br> |
| Other: Matched patient<br>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