To compare radiological and functional outcome in 2 retrospective cohorts. We compare the results of the MILAN study with a cohort after changing our operative strategy in 2010.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome will be evaluated by AAOS- (and AOFAS)-questionnaires. Both
questionnaires are developed for ankle and foot problems only. Additionally,
the VAS-pain is taken and a functional range of motion test of the injured and
contralateral ankle is taken.
Secondary outcome
Osteoarthritis will be measured on X-ray according to the Kellgren-Lawrence
scale.
Background summary
The optimal treatment in trimalleolar fractures remain unclear. Especially, if
and how a posterior malleolar fracture needs to be fixed. Five years ago, a
posterior malleolar fracture was fixed by percutaneous anterio-posterior screw
fixation. Nowadays, the posterior malleolar fracture is fixed by a
posterolateral approach which leads to a direct and anatomical reposition. It
remains unclear if these theoretical advantages leads to a better functional
and radiological outcome.
Study objective
To compare radiological and functional outcome in 2 retrospective cohorts. We
compare the results of the MILAN study with a cohort after changing our
operative strategy in 2010.
Study design
All patients with operative fixation of a trimalleolar fracture between Januar
1st 2011 and December 31st 2013 will be invited to visit the outpatient clinic
for X-ray of the ankle, questionnaires and a functional test. Outcome of these
patients will be compared with another cohort which was invited earlier
(MILAN-study) with almost the same follow-up period.
Study burden and risks
Compared with the yearly dose of background radiation the additional radiation
doser of 1 X-ray is such low that this risk is negligible according to the
investigators.
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
>18 years old at time of trauma and <75 years old at time of follow-up
Open reduction and Internal Fixation of trimalleolar fracture
Exclusion criteria
History of ankle fracture.
Pre-existent impairment in mobility
Inability to speak the Dutch language.
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 | NL55397.098.15 |