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

NCT ID: NCT01814384

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type OTHER

prosthesis GMK ® without the ancillary MyKnee ® LBS

Intervention Type DEVICE

Matched patient

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

Group Type OTHER

Matched patient cutting blocks MyKnee ® LBS

Intervention Type DEVICE

Interventions

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prosthesis GMK ® without the ancillary MyKnee ® LBS

Intervention Type DEVICE

Matched patient cutting blocks MyKnee ® LBS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Nantes

Nantes, France, France

Site Status

Countries

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France

Other Identifiers

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RC 12_0100

Identifier Type: -

Identifier Source: org_study_id

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