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Clinical Trials/NCT01818401
NCT01818401
Active, not recruiting
Not Applicable

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.

Nantes University Hospital1 site in 1 country95 target enrollmentMarch 2013
ConditionsOsteoarthritis

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2025
Last Updated
8 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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