Research with human participants

Overview of medical research in the Netherlands

Medical Aspects of Implant Removal after Osteosynthesis

Published:
Last updated:

nvt

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Fractures
Study type
Observational non invasive

ID

NL-OMON33611

Source

ToetsingOnline

Brief title

the Implant Removal Trial

Condition

  • Fractures
  • Bone and joint therapeutic procedures

Synonym

metal removal

Research involving

Human

Sponsors and support

Primary sponsor :
Amphia Ziekenhuis
Source(s) of monetary or material Support :
niet van toepassing eigen budget

Intervention

Keyword :
implant, ostheosynthesis, removal

Outcome measures

Primary outcome

nvt

Secondary outcome

nvt

Background summary

nvt

Study objective

nvt

Study design

nvt

Study burden and risks

nvt

Public
Amphia Ziekenhuis

Molengracht 21 Postbus 90158
4800 RK Breda
NL
Scientific
Amphia Ziekenhuis

Molengracht 21 Postbus 90158
4800 RK Breda
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

18 years of age and older
consolidated fracture at least one year old
informed consent
plate or nail osteosynthesis (clavicula, ulna, radius, femur, tibia)

Exclusion criteria

younger than 18 years
a fracture that isn't healed
implants on an other location as mentioned in the inclusion criteria

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
300
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 27207
Source: Nationaal Trial Register
Title: The Implant Removal Trial

In other registers

Register ID
CCMO NL15133.008.07
OMON NL-OMON27207