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Long-term results of fixated olecranon fractures; evaluation of 235 patients with a minimum 1 year follow-up


- candidate number25274
- NTR NumberNTR6022
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2016
- Secondary IDsNL51401.094.15 
- Public TitleLong-term results of fixated olecranon fractures; evaluation of 235 patients with a minimum 1 year follow-up
- Scientific TitleLong-term results of fixated olecranon fractures; evaluation of 235 patients with a minimum 1 year follow-up
- ACRONYMLOFFT-study
- hypothesisThere 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
- Healt Condition(s) or Problem(s) studiedOlecranon fractures, Plate fixation
- Inclusion criteriaPatients (°› 16 years) with an olecranon fracture which has been treated with TBW
or PF
- All patients should understand Dutch
- Exclusion criteriaBilateral 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-sep-2016
- planned closingdate1-sep-2017
- Target number of participants235
- Interventions- Mayo Elbow Performance Index (questionnaire)
- testing of range of motion
- Disabilities of the Arm, Shoulder and Hand (questionnaire)
- Primary outcomeSubjective functionality of the operated elbow measured by the DASH
- Secondary outcomeThe objective functionality of the elbow measured by the MEPI and range of motion of the operated elbow and compared to the non-operated elbow
- TimepointsOne
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES ALE Terstappen
- CONTACT for SCIENTIFIC QUERIES ALE Terstappen
- Sponsor/Initiator Foreest Institute Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summarySUMMARY

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°Įs 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 (°›16 year at the moment of fracturing and °›18 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.
- Main changes (audit trail)
- RECORD9-sep-2016 - 12-okt-2016


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