Materialise X-ray Knee Guides for Total Knee Arthroplasty

April 4, 2018 updated by: Materialise

Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Reet, Belgium, 2840
        • AZ Heilige Familie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: X-Ray Knee Guide group
Total knee arthroplasy using Materialise X-Ray Knee Guides
Device: X-Ray Knee Guide group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
Time Frame: 2 Months post-operatively
2 Months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materialise

Investigators

  • Principal Investigator: Roger Jaeken, MD, AZ Heilige Familie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SMAT007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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