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

NCT01814384 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

prosthesis GMK ® without the ancillary MyKnee ® LBS

DEVICE

Matched patient cutting blocks MyKnee ® LBS

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814384 on ClinicalTrials.gov