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 |
| Secondary identifying numbers | IRB/287/16 |
- 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
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
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 |
| jharrison@ao-alliance.org |
Study information
| Study design | Multi-centre interventional single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | Created in Amharic and relevant local languages but not web based |
| 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 | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 01/02/2024 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 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
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Ethiopia
Ethiopia
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Ethiopia
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Ethiopia
Ethiopia
Ethiopia
Ethiopia
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Ethiopia
Sponsor information
Charity
Davos
Davos
7270
Switzerland
| Phone | +41 (0)792566712 |
|---|---|
| cmartin@ao-alliance.org | |
| Website | https://ao-alliance.org/ |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an open access peer reviewed journal |
| 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 |
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.
