Materialise X-ray Knee Guides for Total Knee Arthroplasty

Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02713906
• Other study ID #: SMAT007
• Status: Terminated
• Phase: N/A
• First received: September 25, 2015
• Last updated: April 4, 2018
• Start date: September 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2018
• Source: Materialise
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Knee
• Replacement

Intervention

Device:
• X-Ray Knee Guide group

Locations

Country	Name	City	State
Belgium	AZ Heilige Familie	Reet

Sponsors (1)

Lead Sponsor	Collaborator
Materialise

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods		2 Months post-operatively