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Trial registered on ANZCTR


Registration number
ACTRN12614000588695
Ethics application status
Approved
Date submitted
27/05/2014
Date registered
3/06/2014
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SOFIE: Surgery for Olecranon Fractures In the Elderly: a randomised controlled trial of operative versus non-operative treatment.
Scientific title
A randomised trial of surgical fixation versus non-operative treatment for isolated displaced olecranon fractures in patients aged 75 and over, comparing upper limb function at one year
Secondary ID [1] 284675 0
None
Universal Trial Number (UTN)
U1111-1157-4090
Trial acronym
SOFIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Olecranon fracture 292015 0
Condition category
Condition code
Musculoskeletal 292361 292361 0 0
Other muscular and skeletal disorders
Injuries and Accidents 292393 292393 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Operative fracture fixation.
This involves open surgical repair of the fracture ends using either wires or a plate to hold the bones in place. The procedure takes approximately one hour. It is performed by an orthopaedic surgeon or orthopaedic surgeon in training.
Intervention code [1] 289459 0
Treatment: Surgery
Comparator / control treatment
Non-operative treatment.
This involves symptomatic relief by placing the broken elbow in a sling, or using a plaster splint if necessary. This is only used for up to two weeks, as participants will be encouraged to use the arm normally as the pain improves.
Control group
Active

Outcomes
Primary outcome [1] 292216 0
DASH: Disability of the Arm, Shoulder and Hand score
Timepoint [1] 292216 0
One year
Secondary outcome [1] 308434 0
Range of motion (flexion-extension) of the elbow joint measured with a goniometer.
Timepoint [1] 308434 0
3 months and 12 months
Secondary outcome [2] 308435 0
Pain (visual analogue scale)
Timepoint [2] 308435 0
3 months and 12 months
Secondary outcome [3] 308436 0
Complications (re-operation, readmission, infection, death)
Timepoint [3] 308436 0
Up to one year
Secondary outcome [4] 308614 0
EQ-VAS (Visual analogue scale for health-related quality of life)
Timepoint [4] 308614 0
3 months and 12 months
Secondary outcome [5] 373472 0
Elbow extension strength using a dynamometer
Timepoint [5] 373472 0
3 and 12 months

Eligibility
Key inclusion criteria
Isolated, displaced olecranon fracture within two weeks of injury
Minimum age
75 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Associated upper limb fracture or dislocation
Associated ligamentous injury
Open injury
Flipped fragment
Inability to consent
Inability to understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants invited to participate during admission with isolated displaced olecranon fracture.
After consent obtained, treatment allocation will be by central, telephone based randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Centrally located, computer-generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical tests.
Comparison of DASH and pain scores using unpaired, two-tailed t test. Comparison of complication rates by chi squared test or Fisher's exact test. Intention to treat analysis (primary). As treated analysis (secondary).

Sample size calculation.
Based on having 95% power to detect the minimum clinically important difference (15 points) at a significance level of 0.05, 26 patients are required in each group (SD = 15). Allowing for 20% loss to follow up, we aim to recruit 65 patients.
The minimum clinically important difference of 15 points (in a 100 point scale) is suggested by the developers of the DASH score (http://www.dash.iwh.on.ca/). Such a difference is needed to be achieved by surgery in order to justify the additional costs and risks of surgery compared to non-operative treatment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 2503 0
Gosford Hospital - Gosford
Recruitment hospital [2] 2504 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [3] 2505 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 2506 0
St George Hospital - Kogarah
Recruitment hospital [5] 2507 0
The Sutherland Hospital - Caringbah
Recruitment hospital [6] 2508 0
Orange Health Service - Orange
Recruitment hospital [7] 14405 0
Mackay Base Hospital - Mackay
Recruitment hospital [8] 14406 0
Launceston General Hospital - Launceston
Recruitment hospital [9] 14407 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 14408 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [11] 14409 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [12] 14410 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [13] 14411 0
Cairns Base Hospital - Cairns
Recruitment hospital [14] 14412 0
Prince of Wales Hospital - Randwick
Recruitment hospital [15] 14413 0
John Hunter Hospital - New Lambton
Recruitment hospital [16] 14414 0
Concord Repatriation Hospital - Concord
Recruitment hospital [17] 14415 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [18] 14416 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 27415 0
4740 - Mackay
Recruitment postcode(s) [2] 27416 0
7250 - Launceston
Recruitment postcode(s) [3] 27417 0
2065 - St Leonards
Recruitment postcode(s) [4] 27418 0
2830 - Dubbo
Recruitment postcode(s) [5] 27419 0
4575 - Birtinya
Recruitment postcode(s) [6] 27420 0
2050 - Camperdown
Recruitment postcode(s) [7] 27421 0
4870 - Cairns
Recruitment postcode(s) [8] 27422 0
2031 - Randwick
Recruitment postcode(s) [9] 27423 0
2305 - New Lambton
Recruitment postcode(s) [10] 27424 0
2139 - Concord
Recruitment postcode(s) [11] 27425 0
4029 - Herston
Recruitment postcode(s) [12] 27426 0
3121 - Richmond
Recruitment outside Australia
Country [1] 21741 0
New Zealand
State/province [1] 21741 0
Wellington

Funding & Sponsors
Funding source category [1] 289299 0
Charities/Societies/Foundations
Name [1] 289299 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Address [1] 289299 0
Level 2, 1 Campbell St
Liverpool, NSW
2170
Country [1] 289299 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Address
Level 2, 1 Campbell St
Liverpool, NSW
2170
Country
Australia
Secondary sponsor category [1] 287969 0
None
Name [1] 287969 0
Address [1] 287969 0
Country [1] 287969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291063 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291063 0
Locked Bag 1
New Lambton, NSW
2305
Ethics committee country [1] 291063 0
Australia
Date submitted for ethics approval [1] 291063 0
16/10/2013
Approval date [1] 291063 0
06/12/2013
Ethics approval number [1] 291063 0
13/10/16/4.04

Summary
Brief summary
BACKGROUND
Operative treatment (surgery) is currently the standard way of treating displaced fractures of the olecranon. There is some evidence that good results can be achieved by treating these injuries non-operatively (without surgery). A direct comparison of these treatment methods is needed.
AIM
This study aims to determine if operative fixation (surgery) is superior to non-operative treatment for isolated displaced fractures of the olecranon (elbow tip) in patients presenting with recent fractures who are aged 75 years or older.
HYPOTHESIS
It is our hypothesis that operative treatment yields superior elbow pain and function after one year, compared to non-operative treatment.
PARTICIPANTS
Participants will be selected from patients who present to participating hospitals with olecranon fractures that have occurred within the last 2 weeks, who are eligible for the study. They will be randomised to one of the two treatment arms of the study (operative or non-operative treatment).
OUTCOMES
Participants will be followed for one year, and the function and pain in the elbow, as well as any complications and their X-rays will be compared.
Trial website
Trial related presentations / publications
Symes M, Harris IA, Limbers J, Joshi M. SOFIE: Surgery for Olecranon Fractures in the Elderly: a randomised controlled trial of operative versus non-operative treatment. BMC Musculoskelet Disord. 2015;16:324.
Public notes

Contacts
Principal investigator
Name 48734 0
Prof Ian Harris
Address 48734 0
Whitlam Orthopaedic Research Centre
Ingham Institute for Applied Medical Research
Level 2
1 Campbell St
Liverpool, NSW, 2170
Country 48734 0
Australia
Phone 48734 0
+61287389254
Fax 48734 0
Email 48734 0
ianharris@unsw.edu.au
Contact person for public queries
Name 48735 0
Prof Ian Harris
Address 48735 0
Whitlam Orthopaedic Research Centre
Ingham Institute for Applied Medical Research
Level 2
1 Campbell St
Liverpool, NSW, 2170
Country 48735 0
Australia
Phone 48735 0
+61287389254
Fax 48735 0
Email 48735 0
ianharris@unsw.edu.au
Contact person for scientific queries
Name 48736 0
Prof Ian Harris
Address 48736 0
Whitlam Orthopaedic Research Centre
Ingham Institute for Applied Medical Research
Level 2
1 Campbell St
Liverpool, NSW, 2170
Country 48736 0
Australia
Phone 48736 0
+61287389254
Fax 48736 0
Email 48736 0
ianharris@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All, deidentified
When will data be available (start and end dates)?
After / with study publication estimated to be 1/1/2021. No end date determined.
Available to whom?
Public
Available for what types of analyses?
Any
How or where can data be obtained?
UNSW repository
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 3452 0
Study protocol
Citation [1] 3452 0
Symes M, Harris IA, Limbers J, Joshi M. SOFIE: Surgery for Olecranon Fractures in the Elderly: a randomised controlled trial of operative versus non-operative treatment.
BMC Musculoskeletal Disorders 2015;16:324
Email [1] 3452 0
Other [1] 3452 0
Attachment [1] 3452 0
Summary results
No Results