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. (My Knee) (MY Knee)

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: Osteoarthritis

Treatments: Device: Matched patient cutting blocks MyKnee ® LBS; Device: the prosthesis GMK ® without the ancillary MyKnee ® LBS

Study type: Interventional

Funder types: Other

Identifiers

NCT01818401

RC12_0100

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Control group

Other group

Description:

The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.

Treatment:

Device: the prosthesis GMK ® without the ancillary MyKnee ® LBS

Matched patient

Other group

Description:

The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.

Treatment:

Device: Matched patient cutting blocks MyKnee ® LBS