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

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01814384
• Other study ID #: RC 12_0100
• Status: Active, not recruiting
• Phase: N/A
• First received: March 11, 2013
• Last updated: September 3, 2015
• Start date: March 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

• Matched patient cutting blocks MyKnee ® LBS

Locations

Country	Name	City	State
France	University Hospital of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the functionality of the knee after installation of a total knee replacement between the 2 groups	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.	2 years after	No
Secondary	to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary		2 years after	No
Secondary	medico-economic evaluation type "Cost minimization"	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.	2 years after	No