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Clinical Trials/NCT01814384
NCT01814384
Unknown
Not Applicable

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

Nantes University Hospital1 site in 1 country100 target enrollmentMarch 2013
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Nantes University Hospital
Enrollment
100
Locations
1
Primary Endpoint
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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