ClinicalTrials.gg
TerminatedNCT02713906Updated Apr 5, 2018

Materialise X-ray Knee Guides for Total Knee Arthroplasty

An interventional study of X-Ray Knee Guide group in Arthroplasty, Replacement and Knee, sponsored by Materialise. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Materialise · Not applicable, Interventional, and Treatment

Why this study was terminated
Investigational device not available anymore.

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Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arthroplasty
  • Replacement
  • Knee
03

In context

Lead sponsor

Materialise is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form
  • Comply with the indications listed in the Instructions for Use
  • Be able to undergo a CT scan

Exclusion criteria

Exclusion Criteria:

  • Fulfilling one of the mentioned in the Instructions for Use
  • Pregnant
  • A prisoner
  • Reported to have mental illness or belonged to a vulnerable population
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    X-Ray Knee Guide group

    Total knee arthroplasy using Materialise X-Ray Knee Guides

    Device: X-Ray Knee Guide group

Interventions

  • DeviceX-Ray Knee Guide group
06

What researchers measure

Primary outcomes

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

    Time frame: 2 Months post-operatively

07

Study locations

1 site
  • AZ Heilige Familie
    Reet, 2840, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2015
First posted
Mar 21, 2016
Start
Sep 2015
Primary completionActual
Apr 2017
CompletionActual
Apr 2017
Last update
Apr 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02713906
Lead sponsor
Materialise
Responsible party
Sponsor
First posted
Mar 21, 2016
Start date
Sep 2015
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Apr 5, 2018

Study contacts

Roger Jaeken, MD
principal investigator · AZ Heilige Familie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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