Aim of the project:1) The objective of this retrospective study is to compare a matched group (age, sex and ASA) of operatively treated patients with an ankle fracture including a posterior malleolar fragment with a group operatively treated…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome of standardised questionnaires
Secondary outcome
Outcome X-Ray
Outcome CT-scan
Outcome range of motion
Outcome stability of the joint
Outcome VAS score
Outcome neurovasculaire status
Background summary
A posterior malleolar fracture can be treated surgically or conservatively. The
latter is preferred as surgery is complicated because of the difficulties of
the surgical approach and demanding surgical techniques to adequately reduce
the fragment. Current treatment algorithms, based on level IV evidence, suggest
that patients with posterior malleolus fractures that consist of 25% - 33% of
the tibial plafond need anatomical surgical reduction. This algorithm seems
arbitrary, not only because the lack of evidence, but moreover since the
measurements have all been made on plain lateral radiographs. A variety of
combinations from large fracture fragments with small articular involvement, to
shell fragments with significant articular involvement including extension into
the medial malleolus can be found based on computed tomograpy. It is unclear
how these fractures appear on plain lateral radiographs.
Study objective
Aim of the project:
1) The objective of this retrospective study is to compare a matched group
(age, sex and ASA) of operatively treated patients with an ankle fracture
including a posterior malleolar fragment with a group operatively treated
patients with an ankle fracture without a posterior malleolar fragment using
standardized patient- and physician-based outcome instruments.
2) The objective of this retrospective study is to compare a matched group
(age, sex, and ASA) of operatively treated patients with an ankle fracture
including a posterior malleolar fragment with a group conservatively treated
patients with an ankle fracture including a posterior malleolar fragment using
standardized patient- and physician-based outcome instruments.
3) The objective of this study is to look what the reliability is of the
post-op radiographs compared to our Q3DCT*s as gold standard.
Study design
Evaluate retrospective series of +/- 100 patients with ankle fractures with
available rontgen scans. The Patients are treated at the AMC Amsterdam and the
follow up is 10 to 30 years. The patients will be divided in groups with or
without a posterior malleolair fragment and divided in groups where the
posterior malleolair fragment is operatively treated or conservatively treated.
Visitors (tourists, exchange students) and patients who have died are excluded
from the study. Furthermore patients with nerve damage, severe central nervous
system injuries, patients who are mentally challenged, and patients who have
musculoskeletal disorder (Paget disease, haemochromatosis).
Invitation letters are sent to possible candidates. An oppointment is arranged
at a time of the subject's convenience. Informed consent is obtained prior to
interview, examination, radiographs and tomographs. The invitations are send by
2 independent observers, Diederik Meijer and Barend Gevers Deynoot, on behalf
of dr GMMJ Kerkhoffs.
First, a researcher interviews the subject about the history of their injury
and about their current health status. The subject then completes a set of
questionnaires about their health and about how their injured ankle feels.
Patients may skip any questions they choose not to answer.
The affected ankel will get an x-ray and a CT-scan as it would be done
clinically. The healthy ankle will get an x-ray for comparison. After the x-ray
and the ct-scan, the researcher examines the subjects injured ankle and
performs relevant range-of-motion measurements.
Patients attend a 60-minute visit in our clinic
Statistical analysis will be done with SPSS.
Study burden and risks
The only risks associated with participation are the risks associated with the
amount of ionizing radiation used to obtain tomographs of the injured ankle and
a series of radiographs of both ankles. Dr. ir. G.J. Streekstra at the AMC
calculated the risks and categorized it as 1 (<0,1 mSv) of the IRCP
(international commission of radiological protection), which is qualified as a
trivial risk. Therefore the medical ethical commission of the AMC gave
dispensation for a special insurance for the patients.
Patients might feel some discomfort while answering the questionnaires.
Participation in the study is not likely to result in any direct benefit to the
subjects. On the other hand, patients who elect to participate will get a free
update on the status of their ankle, another chance to have all of their
questions answered, and an initial evaluation of any curent problems. The major
benefit of this study will be to patients who sustain these types of injuries
in the future. A careful analysis of our results of treatment will lead to
improved outcomes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Subjects with a history of ankle fractures who have completed their normal care in the Orthopaedic Service will be invited to return for a long-term follow-up visit.
Exclusion criteria
Visitors (tourists, exchange students) are excluded from the study and patients who have died. Furthermore patients with nervedamage, severe central nervous system injuries, patients who has mentally challenged, and patients who have musculoskeletal disorder (Paget disease, haemochromatosis).
Design
Recruitment
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 |
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CCMO | NL45568.018.13 |