Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Osteoarthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01814384

RC 12_0100

Details and patient eligibility

About

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.

Enrollment: 100 estimated 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)

---

100 participants in 2 patient groups

Control group

Other group

Description:

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

Treatment:

Device: prosthesis GMK ® without the ancillary MyKnee ® LBS

Matched patient

Other group

Description:

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

Treatment:

Device: Matched patient cutting blocks MyKnee ® LBS