NCT02713906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

September 25, 2015

Last Update Submit

April 4, 2018

Conditions

ArthroplastyReplacementKnee

Outcome Measures

Primary Outcomes (1)

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

    2 Months post-operatively

Study Arms (1)

X-Ray Knee Guide group

EXPERIMENTAL

Total knee arthroplasy using Materialise X-Ray Knee Guides

Device: X-Ray Knee Guide group

Interventions

X-Ray Knee Guide groupDEVICE
X-Ray Knee Guide group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Heilige Familie

Reet, 2840, Belgium

Location

Study Officials

  • Roger Jaeken, MD

    AZ Heilige Familie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2015

First Posted

March 21, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

BE(1)