This trial is active, not recruiting.

Condition osteoarthritis
Treatments 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 NCT01814384, RC 12_0100


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.

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
Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
prosthesis gmk ® without the ancillary myknee ® lbs
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 Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Nantes University Hospital.