To asses if there is a difference in functional outcome between open reduction and fixation of the posterior fragment in trimalleolar AO-Weber B fractures with additional medium-sized posterior fragment (5-25% of the involved articular surface, AO…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The functional outcome of the ankle will be evaluated using the American
Orthopaedic Foot and Ankle Society score (AOFAS).
This scoring system is exclusively developed for injury of the ankle and is
worldwide the most used and best scoring system for long-term functional
outcome. In this questionnaire the aspects of pain, function, stiffness,
swelling and the rate of giving way of the ankle will be evaluated in 25
questions. After completion of this questionnaire the obtained score will be
between 0 and 100. The lower the obtained score, the worse the ankle function.
The scoring system is validated and patient-friendly.
Secondary outcome
- VAS-pain
- Olerud & Molander ankle score (short term)
- AOFAS foot and ankle score (long term)
- Range of motion
- Osteoarthritis (AO-scale)
- Complications
- Secondary interventions/reoperations
- Tibiotalar gap or step-off (CT scan postoperatively)
Background summary
Ankle fractures are frequently (incidence 2 in 1000 people per year) seen in
the emergency department of hospitals. In most cases (67%) there is a fracture
of the lateral or medial malleolus (unimalleolar), in a quarter of the cases of
a bimalleolar fracture and in the remaining 7% of the ankle fractures there is
also a fracture at the posterior side of the distal tibia (tertius fragment), a
trimalleolar fracture.
Despite the prominent place that ankle fractures occupy within (orthopedic)
trauma surgery, relatively little is known about the long-term prognosis of
these injuries. Trimalleolar fractures may have a worse prognosis for function
and pain than uni- / bimalleolar fractures, with an important predictive role
for the tertius fragment. There is still no consensus about the influence of
the size of the fragment, the degree of dislocation and the best treatment.
Theories about the influence of tertius fragments on the clinical prognosis
come from, among other things, biomechanical studies. The central idea here is
that long-term development of osteoarthritis is dependent on the size of the
contact surface in the tibiotal joint. Macko investigated the influence of the
size of the tertius fragment on the contact surface in 1991 by means of a
cadaver study with 8 ankles. He described that a larger tertius fragment
resulted in a smaller contact surface. Hartford also confirmed this in a study
of 16 cadavers. Macko assumes a relevant reduced contact surface for a tertius
fragment larger than 25% of the tibiotalar joint surface, while Hartford shows
that this is only the case at a size of 33%. On the basis of these studies,
they argue that obtaining the largest possible contact surface in the tibiotal
joint reduces the risk of osteoarthritis. That is why they advise striving for
the largest possible contact surface and thus the best possible anatomical
position.
Recent studies indicate that a postoperative step-off is a superior predictor
of functional outcome and the development of osteoarthritis. Therefore,
fixation via a direct exposure of the posterior tibia via a posterolateral
approach in the prone position, followed by open reduction and fixation with
screws in the posterior-anterior direction or antiglide plate has gained
popularity. It is unclear whether this approach leads to less development of
osteoarthritis and a better functional outcome.
The multicentre POSTFIX study (RCT) has been set up at the HMC to answer this
question (intended end date summer 2021). This is a continuation of that study.
Study objective
To asses if there is a difference in functional outcome between open reduction
and fixation of the posterior fragment in trimalleolar AO-Weber B fractures
with additional medium-sized posterior fragment (5-25% of the involved
articular surface, AO type 44-B3) and no fixation of the posterior malleolar
fragment assessed by the AOFAS-score after 4-7 years.
Study design
Retrospective cohort study.
Study burden and risks
Participants of this study will not benefit directly by participating, other
than the opportunity to receive extra information if they experience any
problems or have any questions regarding their operated ankles during the visit
to the outpatient clinic. The extra radiation exposure of the X-rays is about
1/100th of the background radiation and does not outweigh the benefits of this
study.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
1) Age between 18 and 75 years at time of trauma
2) First ankle fracture of the affected side
3) Trimalleolar AO-Weber B fracture with additional medium-sized posterior
fragment (5-25% of the involved articular surface, AO type 44-B3)
Exclusion criteria
1) Severe traumatized patients
2) Multiple fractures during visit emergency department
3) Ankle fracture of the same ankle in the history
4) Patients with pre-existent mobility problems
5) Pre-existent disability
6) Patients living in another region and follow-up will take place in another
hospital
7) Inability to speak the Dutch language
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL77804.058.21 |