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Materialise X-ray Knee Guides for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02713906
Recruitment Status : Terminated (Investigational device not available anymore.)
First Posted : March 21, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Materialise

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty Replacement Knee Device: X-Ray Knee Guide group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty
Study Start Date : September 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

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



Primary Outcome Measures :
  1. Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods [ Time Frame: 2 Months post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713906


Locations
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Belgium
AZ Heilige Familie
Reet, Belgium, 2840
Sponsors and Collaborators
Materialise
Investigators
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Principal Investigator: Roger Jaeken, MD AZ Heilige Familie

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Responsible Party: Materialise
ClinicalTrials.gov Identifier: NCT02713906     History of Changes
Other Study ID Numbers: SMAT007
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018