Materialise X-ray Knee Guides for Total Knee Arthroplasty

NCT ID: NCT02713906

Last Updated: 2018-04-05

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

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-04-30

Brief Summary

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The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.

Detailed Description

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Conditions

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Arthroplasty Replacement Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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X-Ray Knee Guide group

Total knee arthroplasy using Materialise X-Ray Knee Guides

Group Type EXPERIMENTAL

X-Ray Knee Guide group

Intervention Type DEVICE

Interventions

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X-Ray Knee Guide group

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Physically and mentally able and willing to comply with the protocol
* Be treated for a primary total knee arthroplasty
* Are fluent in Dutch or French
* Sign the Informed Consent Form
* Comply with the indications listed in the Instructions for Use
* Be able to undergo a CT scan

Exclusion Criteria

* Fulfilling one of the contraindications mentioned in the Instructions for Use
* Pregnant
* A prisoner
* Reported to have mental illness or belonged to a vulnerable population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Materialise

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Jaeken, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Heilige Familie

Locations

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AZ Heilige Familie

Reet, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SMAT007

Identifier Type: -

Identifier Source: org_study_id

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