ANZCTR - Registration

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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

3/10/2023

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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

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]

DASH: Disability of the Arm, Shoulder and Hand score

Timepoint [1]

One year

Secondary outcome [1]

Range of motion (flexion-extension) of the elbow joint measured with a goniometer.

Timepoint [1]

3 months and 12 months

Secondary outcome [2]

Pain (visual analogue scale)

Timepoint [2]

3 months and 12 months

Secondary outcome [3]

Complications (re-operation, readmission, infection, death)

Timepoint [3]

Up to one year

Secondary outcome [4]

EQ-VAS (Visual analogue scale for health-related quality of life)

Timepoint [4]

3 months and 12 months

Secondary outcome [5]

Elbow extension strength using a dynamometer

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/07/2014

Actual

16/10/2014

Date of last participant enrolment

Anticipated

Actual

19/10/2022

Date of last data collection

Anticipated

Actual

1/10/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,TAS,VIC

Recruitment hospital [1]

Gosford Hospital - Gosford

Recruitment hospital [2]

Wyong Public Hospital - Hamlyn Terrace

Recruitment hospital [3]

Liverpool Hospital - Liverpool

Recruitment hospital [4]

St George Hospital - Kogarah

Recruitment hospital [5]

The Sutherland Hospital - Caringbah

Recruitment hospital [6]

Orange Health Service - Orange

Recruitment hospital [7]

Mackay Base Hospital - Mackay

Recruitment hospital [8]

Launceston General Hospital - Launceston

Recruitment hospital [9]

Royal North Shore Hospital - St Leonards

Recruitment hospital [10]

Dubbo Base Hospital - Dubbo

Recruitment hospital [11]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [12]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [13]

Cairns Base Hospital - Cairns

Recruitment hospital [14]

Prince of Wales Hospital - Randwick

Recruitment hospital [15]

John Hunter Hospital - New Lambton

Recruitment hospital [16]

Concord Repatriation Hospital - Concord

Recruitment hospital [17]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [18]

Epworth Richmond - Richmond

Recruitment postcode(s) [1]

4740 - Mackay

Recruitment postcode(s) [2]

7250 - Launceston

Recruitment postcode(s) [3]

2065 - St Leonards

Recruitment postcode(s) [4]

2830 - Dubbo

Recruitment postcode(s) [5]

4575 - Birtinya

Recruitment postcode(s) [6]

2050 - Camperdown

Recruitment postcode(s) [7]

4870 - Cairns

Recruitment postcode(s) [8]

2031 - Randwick

Recruitment postcode(s) [9]

2305 - New Lambton

Recruitment postcode(s) [10]

2139 - Concord

Recruitment postcode(s) [11]

4029 - Herston

Recruitment postcode(s) [12]

3121 - Richmond

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research

Address [1]

Level 2, 1 Campbell St Liverpool, NSW 2170

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1
New Lambton, NSW
2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/10/2013

Approval date [1]

06/12/2013

Ethics approval number [1]

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

Prof Ian Harris

Address

Whitlam Orthopaedic Research Centre Ingham Institute for Applied Medical Research Level 2 1 Campbell St Liverpool, NSW, 2170

Country

Australia

Phone

+61287389254

Fax

[email protected]

Contact person for public queries

Name

Ian Harris

Address

Whitlam Orthopaedic Research Centre Ingham Institute for Applied Medical Research Level 2 1 Campbell St Liverpool, NSW, 2170

Country

Australia

Phone

+61287389254

Fax

[email protected]

Contact person for scientific queries

Name

Ian Harris

Address

Whitlam Orthopaedic Research Centre Ingham Institute for Applied Medical Research Level 2 1 Campbell St Liverpool, NSW, 2170

Country

Australia

Phone

+61287389254

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Public

Conditions for requesting access:
• -

What individual participant data might be shared?

• All, deidentified

What types of analyses could be done with individual participant data?

• Any

When can requests for individual participant data be made (start and end dates)?

From:
After / with study publication estimated to be 1/1/2021. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• UNSW repository

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3452	Study protocol	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	https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0789-6

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	SOFIE: Surgery for Olecranon Fractures in the Elderly: A randomised controlled trial of operative versus non-operative treatment Orthopedics and biomechanics.	2015	https://dx.doi.org/10.1186/s12891-015-0789-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically