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Clinical Trials/NCT02713906
NCT02713906
Terminated
Not Applicable

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

Materialise1 site in 1 country3 target enrollmentSeptember 2015
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ConditionsArthroplastyReplacementKnee

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty
Sponsor
Materialise
Enrollment
3
Locations
1
Primary Endpoint
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
Status
Terminated
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
April 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • •A prisoner
  • •Reported to have mental illness or belonged to a vulnerable population

Outcomes

Primary Outcomes

Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods

Time Frame: 2 Months post-operatively

Study Sites (1)

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