Osteoarthritis
Conditions
Keywords
Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis
Brief summary
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.
Interventions
DEVICEprosthesis GMK ® without the ancillary MyKnee ® LBS
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the functionality of the knee after installation of a total knee replacement between the 2 groups | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | * 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. |
Countries
France
Outcome results
None listed