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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)

NCT ID: NCT01818401

Last Updated: 2017-10-09

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

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis

Keywords

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Ancillary tailored medico-economic study, total knee replacement primary or secondary 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

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

Group Type OTHER

the prosthesis GMK ® without the ancillary MyKnee ® LBS

Intervention Type DEVICE

Matched patient

The 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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the 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

Site Status

Countries

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France

Other Identifiers

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RC12_0100

Identifier Type: -

Identifier Source: org_study_id