Materialise X-ray Knee Guides for Total Knee Arthroplasty

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02713906

Enrollment

Registered

2016-03-21

Start date

2015-09-30

Completion date

2017-04-30

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Knee, Replacement

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.

Interventions

DEVICEX-Ray Knee Guide group

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026