No registrations found.
ID
Source
Brief title
Health condition
olecranon fractures, tension band wiring, plate fixation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective functionality of the operated elbow measured by the DASH
Secondary outcome
The objective functionality of the elbow measured by the MEPI and range of motion of the
operated elbow and compared to the non-operated elbow
Background summary
SUMMARY
Rationale:
Olecranon fractures are a common type of fracture with an annual incidence of
approximately 1.15 to 1.2 per 10.000 population (age > 16 year) which constitutes of 18% of
all proximal forearm fractures and occurs in all age groups, but with a predominance in the
older age group. Tension band wiring (TBW) is the oldest and most commonly used
technique of internal fixation for non-comminuted olecranon fractures. Currently, there is a shift detectable from this commonly used TBW to newer fixation techniques such as plate
fixation (PF). However, there is insufficient evidence to draw robust conclusions on the
subjective and objective effects of both TBW and PF, and therefore it is unknown if this shift
is desirable and justified.
Objective:
Aim of this study is to determine the functional outcome after a minimum of 1 year follow-up
after fixation of the fractured olecranon with TBW or PF. Subgroup analyses will be done to
investigate the assumed advantage of PF compared to TBW in comminuted fractures
Study design:
The study will be a retrospective cohort study for all types of olecranon fractures (according
to the Mayo-classification), fixated with TBW or PF.. Data will be collected from patient¡¯s
medical records including clinical charts and radiology reports. A one-time consult will be
held at our outpatient clinic for answering questionnaires and physical examination. This visit
will take approximately one hour in total. The study will be done at the department of surgery
at Medisch Centrum Alkmaar.
Study population:
All patients (¡Ý16 year at the moment of fracturing and ¡Ý18 years at the start of this study)
who received TBW or PF for an olecranon fracture between 2004-2013 at the surgery
department of a level one trauma centre (Medisch Centrum Alkmaar). We expect to included
approximately 210 patients in the TBW-group and 25 patients in the PF-group, based on a
preliminary count.
Main study parameters/endpoints
The primary endpoint of this study is the subjective functionality of the operated elbow
measured by the DASH score. The secondary endpoint will be the range of motion
measured in degrees.
Study objective
There is no difference in terms of function between patients who had an olecranon fracture which has been operated with tension band wiring or with plate fixation
Study design
One
Intervention
- Mayo Elbow Performance Index (questionnaire)
- testing of range of motion
- Disabilities of the Arm, Shoulder and Hand (questionnaire)
Inclusion criteria
Patients (¡Ý 16 years) with an olecranon fracture which has been treated with TBW
or PF
- All patients should understand Dutch
Exclusion criteria
Bilateral olecranon fracture
- Former surgery of the affected olecranon
- Diseases that can affect the elbow function (osteogenesis imperfecta, muscle disease,
rheumatoid arthritis), accept for osteoporosis.
- Mental disability that compromises postoperative treatment
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5756 |
NTR-old | NTR6022 |
CCMO | NL51401.094.15 |
OMON | NL-OMON43886 |