This trial is active, not recruiting.

Condition osteoarthritis
Treatments the prosthesis gmk ® without the ancillary myknee ® lbs, matched patient cutting blocks myknee ® lbs
Sponsor Nantes University Hospital
Start date March 2013
End date September 2016
Trial size 100 participants
Trial identifier NCT01818401, RC12_0100


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
the prosthesis gmk ® without the ancillary myknee ® lbs
The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
matched patient cutting blocks myknee ® lbs

Primary Outcomes

compare the functionality of the knee after installation of a total knee replacement between the 2 groups
time frame: 2 years after

Secondary Outcomes

to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
time frame: 2 years after
medico-economic evaluation type "Cost minimization"
time frame: 2 years after

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.