To evaluate the long term functional and radiological effects of surgical treatment of Weber type C (AO 44-C1/2/3) fibular fractures
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome of the ankle, assessed using the validated completely
patient reported version of the PROM American Orthopaedic Foot and Ankle Score
(PR-AOFAS), which provides a score ranging from 0 (worst possible functional
outcome) to 100 0 (best possible functional outcome).
Secondary outcome
- Functional outcome measured with the PROMIS Physical Function short form 8b.
- Pain measured with a visual analogue scale (VAS)
- The extent of osteoarthritis, assessed on anteroposterior, lateral and
mortise view ra-diopgraph, using the Kellgren and Lawrence score for
osteoarthritis, modified by Ki-jowski et al.
- Complications including secondary interventions/reoperations
Background summary
Despite the prominent position of ankle fractures in the daily practice of
orthopaedic trauma surgery, relatively little is known about the long-term
prognosis of operatively treated Weber C ankle fractures. It is suggested that
Weber C fractures have a clinically less satisfactory outcome, however, large
clinical studies evaluating long-term outcomes are lacking. The aim of this
study is to evaluate the long-term functional and radiological outcome of
surgically treated Weber C ankle fractures.
Study objective
To evaluate the long term functional and radiological effects of surgical
treatment of Weber type C (AO 44-C1/2/3) fibular fractures
Study design
Multicenter 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 injury. The extra radiation
exposure of the X-rays poses a negligible risk since is it represents about
1/100th of the background radiation. The one-time visit to the outpatient
clinic is considered a burden for the patients because it takes time. Filling
out the two short questionnaires is considered to pose a minimal burden.
Lijnbaan 32
Den Haag 2511VA
NL
Lijnbaan 32
Den Haag 2511VA
NL
Listed location countries
Age
Inclusion criteria
- Males or females aged 18 to 75 at the time of trauma and who are competent
and capable to make medical decisions.
- Operated due to a Weber C fracture (AO type 44-C1/2/3) between January 1st
2012 and June 1st 2016.
- Sufficient understanding of the Dutch or English language in order to
independently understand the patient information including informed consent and
complete the follow-up questionnaires.
- Provision of informed consent by the patient.
Exclusion criteria
- Unable to follow up (e.g. deceased, living abroad)
- Pathological fractures
- Multi-extremity fractures or other injuries at time of trauma.
- History of ankle fracture on the same ankle prior to the operation.
- Impaired function of the operated ankle prior to the operation.
- Patients with decreased use of the ankle due to disability of other cause
- Operated on prior to enrolment of the electronic hospital information system
(no availability of digital initial trauma radiographs).
Design
Recruitment
metc-ldd@lumc.nl
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 | NL87654.058.24 |