The primary goal is to determine the degree of independent functioning of the patient with a proximal humeral fracture.A secondary goal is to evaluate all primary and secondary costs during the rehabilitation period after a proximal humeral fracture…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degree of independent functioning is defined as the amount of days a patient
needs nurse care or home care. The costs are accurately determined in euros
during one year in the Dutch health care system. Functional outcome is assessed
using the Dutch validated DASH questionnaire (Veehof 2002) and the Shoulder
Function Assesment Scale (van den Ende 1997 / Vermeulen 2005) and EQ-5D and
SF-12 as a general health score and cost utility measure.
Secondary outcome
Not applicable.
Background summary
Several recent studies warn that the incidence of proximal humeral fractures is
rising with the expanding ageing population (Palvanen 2006, Kannus 2000,
Court-Brown 2006). Also, proximal humeral fractures are known to have severe
impact on upper extremity function (Calvo 2010) Therefore it can be expected
that the consequences, financially as well as workload, on public healthcare
will increase the coming decades. The magnitude of these consequences is likely
to be dependent of someone*s ability to function independently.
It is generally accepted that proximal humeral fractures with displacement of
more than 1 cm, or angulation (tilt) of more than 45* need operative treatment.
But besides the classic work of Neer in 1970, there is still little support for
this advice (Neer 1970, Foruria 2011). Furthermore, in proximal humeral
fractures, there are many different fracture patterns, (and classification
systems) and thus possible treatment strategies. The choice of which treatment
fits best for an individual patient depends on numerous factors, and with lack
of randomized comparative trials, decision making is not based on evidence, but
only on expert opinion with some support from retrospective studies (i.e. level
3 evidence) (Murray 2011, Handoll 2010).
Study objective
The primary goal is to determine the degree of independent functioning of the
patient with a proximal humeral fracture.
A secondary goal is to evaluate all primary and secondary costs during the
rehabilitation period after a proximal humeral fracture.
A third goal is to relate healed proximal fractures to patient functioning in a
virtual dynamic environment (Krekel 2010).
Study design
A multicentre, prospective observational study.
Treatment options, either conservative or surgical will be made by the present
treatment protocols in these centers (i.e. usual care design).
Study burden and risks
The burden of this study consists in the duration of 3 standard outpatient
clinic visits which coincide with the regular outpatient visits. All patients
need to fill in the questionnaires (15 to 30 minutes per questionnaire), which
is extra compared to usual care. An extra CT scan will be made at the end of
the treatment period, to evaluate the healed proximal humeral fracture. The
patient will be exposed to a very low radiation dose of a maximum of 10 mGy.
This amount of radiation has a very little effect on the patient*s health (Hall
et all 2007).
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Listed location countries
Age
Inclusion criteria
- A proximal humeral fracture
- Age 50 years and older
- presenting to emergency department of one of the three involved Medical Centres.
Exclusion criteria
- Polytrauma / other associated injuries
- Pre-existing illness affecting the upper limb function
- Unknown date of fracturing or trauma > 3 weeks ago
- Pathological fracture
- Open fracture
- Associated nerve damage
- Unable to fill in a questionnaire
- No possibility of follow up
- No informed consent
Design
Recruitment
metc-ldd@lumc.nl
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 | NL40852.058.12 |