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)

Not Applicable

Active, not recruiting

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

• Registration Number: NCT01818401
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Primary Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 95

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
Control group	the prosthesis GMK ® without the ancillary MyKnee ® LBS	The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.
Matched patient	Matched patient cutting blocks MyKnee ® LBS	The treated group will consist of patients which the GMK ® prosthesis with 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