Materialise X-ray Knee Guides for Total Knee Arthroplasty

Materialise

Status: Terminated

Conditions: Arthroplasty; Knee; Replacement

Treatments: Device: X-Ray Knee Guide group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02713906

SMAT007

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

X-Ray Knee Guide group

Experimental group

Description:

Total knee arthroplasy using Materialise X-Ray Knee Guides

Treatment:

Device: X-Ray Knee Guide group