Materialise X-ray Knee Guides for Total Knee Arthroplasty

Not Applicable

Terminated

• Conditions: Arthroplasty; Knee; Replacement
• Interventions: Device: X-Ray Knee Guide group

• Registration Number: NCT02713906
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
X-Ray Knee Guide group	X-Ray Knee Guide group	Total knee arthroplasy using Materialise X-Ray Knee Guides

Primary Outcome Measures

Name	Time	Method
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods	2 Months post-operatively

Trial Locations

Locations (1)

AZ Heilige Familie; 🇧🇪 Reet, Belgium