Trial comparing a non-operative and standard operative treatment for children's fractures above the elbow in the low- and middle-income context

ISRCTN	ISRCTN62164933
DOI	https://doi.org/10.1186/ISRCTN62164933
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	IRB/287/16
Sponsor	AO Alliance Foundation
Funder	AO Alliance Foundation

Submission date: 24/07/2024
Registration date: 25/07/2024
Last edited: 25/06/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Supracondylar fractures just above the elbow are common in children and can cause disability throughout life. It is known that some treatments are safer and some are more effective than others. Two treatments are considered to be particularly safe and effective. No study has ever looked at these treatments head to head and no prospective study of these treatments has been done in a low- or middle-income country (LMIC). The study aims to compare these treatments in the LMIC context.

Who can participate
Children aged 3 to 10 years sustaining this specific but common fracture above the elbow and presenting to one of the eight study centres in Ethiopia

What does the study involve?
If after explanation and patient advice sheet a guardian wishes for their child to be entered into the study, and signs the written consent, their child will be randomly allocated to receive one or other of the two recognised treatments. The two recognised treatments are:
1. Non-operative using lateral straight arm traction
2. Operative using closed reduction and percutaneous pinning
After treatment the child will be followed as an outpatient for 6 months, and the guardian will respond to a telephone questionnaire after 3, 6 and 12 months.

What are the possible benefits and risks of participating?
As with other studies the patients are expected to benefit from the study-observer effect whether they have the operative or non-operative treatment option. In normal practice patients may be discharged between 6 and 12 weeks after treatment whereas this study requires a 6-month outpatient attendance (transport will be paid), and a questionnaire response up to 12 months.

Where is the study run from?
The study lead is in Hawassa University Hospital (Ethiopia). External advice and support will come from Chester, UK, and Zurich, Switzerland.

When is the study starting and how long is it expected to run for?
February 2024 to July 2026

Who is funding the study?
AO Alliance Foundation (Switzerland)

Who is the main contact
1. Prof. William James Harrison, jharrison@ao-alliance.org
2. Dr Mengistu Gebreyohanes, mengistugy@gmail.com

Contact information

Prof William James Harrison
Public, Scientific, Principal investigator

Countess of Chester NHS Foundation Trust
Chester
CH21UL
United Kingdom

ORCID ID	0000-0001-7229-0041
Phone	+44 (0)356 0000
Email	jharrison@ao-alliance.org

Study information

Primary study design	Interventional
Study design	Multi-centre interventional single-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of straight arm traction versus operative treatment for displaced pediatric supracondylar humerus fractures: a randomized controlled trial
Study acronym	STOPUS
Study objectives	Non-operative treatment of children's supracondylar humeral fractures using lateral straight arm traction is not inferior to operative treatment using closed reduction and percutaneous pinning.
Ethics approval(s)	Approved 20/06/2024, Hawassa University College of Medicine and Health Sciences IRB (Hawassa University, Ethiopia, Hawassa, 1560 CMHS, Ethiopia; +46 (0)8209290; antenehg@hu.edu.et), ref: IRB/287/16
Health condition(s) or problem(s) studied	Paediatric supracondylar humeral fractures
Intervention	Randomisation (computer generated) between two accepted treatment options to test for non-inferiority in the low- and middle-income country context. The two recognised treatments are: 1. Non-operative using lateral straight arm traction 2. Operative using closed reduction and percutaneous pinning
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Current primary outcome measure as of 15/08/2024: Limb function as measured by the PROM PROMIS Parent Proxy Upper Extremity Short Form 8a version 3.0 administered by blind independent reviewer at 12 months after injury. _____ Previous primary outcome measure: Quality of life measured using PROMIS 7+2 pediatric PROM administered as a telephone questionnaire using blind independent technicians to patient guardians at 3, 6 and 12 months after injury
Key secondary outcome measure(s)	Current secondary outcome measures as of 15/08/2024: 1. Limb function measured by the PROM PROMIS parent proxy upper extremity short form 8a version 3.0 administered by a blind independent reviewer at 6 months after injury. 2. Global health as measured by the PROM PROMIS parent proxy 7+2 version 3.0 administered by a blind independent reviewer at 6 and 12 months after injury. 3. Parent satisfaction with treatment as measured by a visual analogue scale administered by the treating surgeon team at 3 and 6 months after injury. 4. Complications as measured by a checklist administered by treating surgeons 3 and 6 months after injury 5. Flynn's criteria of elbow form and function administered by treating surgeons 3 and 6 months after injury _____ Previous secondary outcome measures: 1. Carrying angle and range of movement at the elbow measured using Flynn's criteria of elbow function clinically in person by treating surgeons at 3 and 6 months after injury 2. Complications measured in person by treating surgeons at 3 and 6 months after injury. Specific recording of nerve injury (radial, median including anterior interosseous, ulnar), vascular injury or compromise, and infection.
Completion date	31/07/2026

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. Patient attending hospital with fresh supracondylar humeral fracture 2. Age range 3 to 10 years
Key exclusion criteria	1. Open fracture 2. Patient with critical ischaemia 3. Delayed presentation after 72 hours of injury
Date of first enrolment	01/08/2024
Date of final enrolment	31/07/2025

Locations

Countries of recruitment

Ethiopia

Study participating centres

Hawassa University Hospital

Hawassa
00000
Ethiopia

Bahir Dar University Hospital

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Ethiopia

St Paul's Hospital

Addis Ababa
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Ethiopia

Black Lion Hospital

Addis Ababa
00000
Ethiopia

Mekele University Hospital

00000
Ethiopia

Gondar University Hospital

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Ethiopia

Jijiga University Hospital

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Ethiopia

Alert Hospital

Addis Ababa
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Ethiopia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Dr Mengistu Gebreyohanes (mengistugy@gmail.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		23/06/2025	25/06/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/06/2025: Publication reference added.
15/08/2024: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
25/07/2024: Study's existence confirmed by the Hawassa University College of Medicine and Health Sciences IRB.