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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Device: Matched patient cutting blocks MyKnee ® LBS; Device: prosthesis GMK ® without the ancillary MyKnee ® LBS

• Registration Number: NCT01814384
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched patient	Matched patient cutting blocks MyKnee ® LBS	Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.
Control group	prosthesis GMK ® without the ancillary MyKnee ® LBS	Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.

Primary Outcome Measures

Name	Time	Method
compare the functionality of the knee after installation of a total knee replacement between the 2 groups	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 Outcome Measures

Name	Time	Method
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	* Compare the costs of implementing the two strategies (A and B) taking into account the resources consumed (operative time, anesthetic drugs, blood bags ...).; * Determine the least costly therapeutic intervention and medico-economic impact in the current system of financing of hospital expenditure.

Trial Locations

Locations (1)

University Hospital of Nantes; 🇫🇷 Nantes, France