Materialise X-ray Knee Guides for Total Knee Arthroplasty | NCT02713906

Studies
Materialise X-ray Knee Guides for Total Knee Arthroplasty

NCT02713906

Sponsor

Materialise

Status

Terminated

Last Update Posted

Apr 5, 2018Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Arthroplasty
Replacement
Knee

Interventions

X-Ray Knee Guide group

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigational device not available anymore.

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Sep 25, 2015

First Submission Date that Met QC Criteria

Mar 15, 2016

First Posted Date

Mar 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
X-Ray Knee Guide group	Experimental	Total knee arthroplasy using Materialise X-Ray Knee Guides	Device: X-Ray Knee Guide group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
X-Ray Knee Guide group	Device		X-Ray Knee Guide group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roger Jaeken, MD	AZ Heilige Familie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Heilige Familie		Reet		2840	Belgium