Olecranon Fractures in the Elderly Clinical Trial
Official title:
A Prospective Randomised Trial of Non-operative Versus Operative Management of Olecranon Fractures in the Elderly
Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures within the elderly population with one case series in the literature describing 13 patients. Our trial includes all patients equal to or over the age of 75yrs presenting to the Edinburgh and Fife Orthopaedic Trauma Units with an isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two treatment methods. Patients in the nonoperative group will be place in a sling for two weeks and then allowed to mobilise under supervised physiotherapy as per normal protocol. For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Patients will be evaluated over a one year period following their treatment.
Patients with undisplaced olecranon fractures can be treated non-operatively. The aims of
treatment in displaced olecranon fractures are the restoration of function and stability to
the elbow joint4. The technique employed should allow preservation and reconstruction of the
articular surface with minimal associated complications. Tension-band wiring (TBW) is the
most recognised and commonly used fixation method, although plate fixation and
intramedullary screw fixation are noted alternatives. Potential problems with the TBW
technique are wound breakdown, infection, prominent metalwork, malunion and non-union.
Furthermore, plate fixation is considered to be superior in distal/comminuted/oblique
fractures and fracture-dislocations, with superior fracture reduction and fixation results,
as well as a lower rate of re-operation.
The above described fixation techniques can be employed in elderly people, although
difficulties associated with fixation in osteoporotic bone, wound breakdown and other
complications is reported. In these patients, fracture excision with advancement of the
triceps is a viable option if fixation is deemed inappropriate. However, there is limited
evidence to suggest that non-operative treatment of displaced olecranon fractures in these
elderly patients may provide adequate functional results. In a case series of 13 patients
(mean age 81.8 years, >5 mm fracture displacement) treated non-operatively for a displaced
olecranon fracture, outcome scores were excellent in 11 patients and poor in one.
Research Aim To determine if any difference exists in outcome (primary measure - DASH score)
after one year between non-operative management AND operative treatment for olecranon
fractures in patients 75yrs or older (≥75yrs).
Methodology This trial involves identifying patients over the age of 75yrs (≥75yrs)
presenting to the Edinburgh Orthopaedic Trauma Unit and Fife Orthopaedic Trauma Unit with an
isolated olecranon fracture. Patients who consent to enrol in the trial will be randomised
to one of two recognised treatment techniques - non-operative management in a collar and
cuff for two weeks OR operative management using tension band wire fixation or plate
fixation. The trial will commence once ethical approval is granted by the Lothian Research
Ethics Committee.
All statistical analysis was/will be performed by Dr Rob Elton. Prior to the study a power
analysis determined the number of patients required in each trial. The primary outcome
measure will be the DASH score, a continuous variable that follows a normal
(Gaussian-shaped) distribution. This study is designed to determine a clinically relevant
mean difference of 10 points between the two cohorts at one year after enrolment. A power
analysis indicated that a total sample size of 50 (25 in each group) subjects will provide
80% statistical power to detect significant differences (0.05) in DASH scores, assuming an
effect size of 0.8 (mean difference of 10 points, standard deviation of 12 points) using an
unpaired t-test. To account for a possible loss to follow-up of up to 25%, we anticipate
enrolling 35 subjects in each cohort for a total sample size of 70 subjects. A p value of <
0.05 was considered statistically significant.
All patients presenting to the units with a fracture of the olecranon that satisfy the
inclusion criteria will be invited to participate in our study. Vulnerable populations will
not be recruited.
A qualified member of the on-call team will introduce the study to the patient and initiate
informed consent. If the patient agrees, a research fellow (Trauma and Orthopaedic StR3
level), not involved with the patient's care will review the study protocol in detail and
address any questions the patient may have. If the patient is willing to participate, the
research fellow will complete the informed consent with the patient. Patients will be given
a copy of the consent form, and be informed that their participation is voluntary and that
they can withdraw at any time during the study without detriment to their normal care in any
way. Patients may take as long as they like to consider participation, provided that they
still meet all the eligibility criteria documented above. Patients that are willing to
participate in this study will get the same care of their fracture as patients that decide
not to participate in the study.
On enrolment, a data collection form will be started with demographic and injury-related
information collected. Patients will be randomised (performed by Dr Rob Elton using closed
opaque envelopes) into one of the two groups (non-operative or operative). Patients in the
non-operative group will be placed in a collar and cuff for two weeks and allowed to
mobilise under supervised physiotherapy as per normal protocol. Patients in this group can
be placed in cast (~60 degrees of flexion) if pain is too severe. For those patients in the
operative group, tension band wire of plate fixation will be employed depending on the
choice of their supervising consultant. Following surgery, the post-operative assessment and
course will be as per normal protocol for patients who are not in this study. Patients in
the operative group will be immobilised depending on fracture fixation during surgery and
the decision will be made by the treating surgeon. Physiotherapy will be arranged when
required
All follow-up assessment will take place during follow-up visits initially with the treating
consultant surgeon's team and a dedicated member of the research team. Radiographs and other
diagnostic studies will be obtained at the discretion of the treating surgeon and will not
differ from routine clinical care.
Follow-up assessment will be collected over a one year period (2 weeks, 6 weeks, 3 months, 6
months and one year). Routine follow-up in our institution for patients who have sustained
an olecranon fracture that is managed operatively involves outpatient clinic reviews with
radiographs at 2 weeks, 6 weeks, three months and six months. Therefore, one additional
visit at 1 year is required for this study with no additional radiographs. Radiographs will
only be performed at one year on clinical indication.
At each visit physical examination, treatment, complications and re-operation (e.g. hardware
removal), for each patient will be recorded. A member of the research team, blinded to the
treatment method by sticking plaster over the entry position, will undertake functional
testing and assessment.
By statistically analysing the outcome scores in the two groups, I aim to better determine
the optimal management of this fracture in this age group. Using univariate analysis and
multivariate regression analysis I will determine significant (p<0.05) predictors of outcome
in relation to functional outcome score (DASH at one year).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment