Research with human participants

Overview of medical research in the Netherlands

*Bone remodeling in transfemoral amputees with a bone-anchored prosthesis after transfemoral amputation.*

Published:
Last updated:

The main objective of the study is to explore the bone remodeling in order to examine long-term stability of the implant after 10 years follow-up.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Bone disorders (excl congenital and fractures)
Study type
Observational non invasive

ID

NL-OMON49955

Source

ToetsingOnline

Brief title

BONEKLICK

Condition

  • Bone disorders (excl congenital and fractures)

Synonym

bone resorption, cortical thinning

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum
Source(s) of monetary or material Support :
Ministerie van OC&W,R0004031 (H2020 780871 MyLeg)

Intervention

Keyword :
amputation, bone remodeling, bone-anchored prosthesis, osseointegration

Outcome measures

Primary outcome

The main study parameter is changes in bone remodelling in terms of bone

density, cortical thickness and distal bone resorption measured with DXA scans

and conventional radiographs.

Secondary outcome

-

Background summary

A Bone-Anchored Prosthesis (BAP) is an alternative solution to a
socket-suspended prosthesis (SSP) of upper-leg prosthesis. It allows
overcoming soft tissue problems and offers better control over the external
prosthetic system by direct attachment to the femoral remnant by means of an
osseointegrated implant (OI). By doing so, the BAP is expected to promote
increased loading of the bone and its remodelling. In an earlier study we
presented the first results of a cohort after two years of follow-up.

Study objective

The main objective of the study is to explore the bone remodeling in order to
examine long-term stability of the implant after 10 years follow-up.

Study design

The study will be a prospective cohort study.

Study burden and risks

No special risks are involved in the study. The radiological examination with
DXA scanner is an approved medical standard.
The most benefits will be present for the future patients, whose treatment will
be possibly improved by the gained knowledge.

Public
Selecteer

Kwartelstraat 7
Nijmegen 6542XL
NL
Scientific
Selecteer

Kwartelstraat 7
Nijmegen 6542XL
NL

Listed location countries

Netherlands

Age

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

Inclusion criteria

participation in 2010-099

Exclusion criteria

Explantation of the osseointegration implant
Removal of the outer part or distal part of the intramedullary stem with
closure of the stump

Design

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

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
27
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

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

No registrations found.

In other registers

Register ID
CCMO NL73215.091.20

Date completed :
Actual enrolment :
18