The humeral shaft fracture trial: surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older
| ISRCTN | ISRCTN17108318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17108318 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 277059 |
| Protocol serial number | HTA - NIHR127817, IRAS 277059 |
| Sponsor | University of Oxford |
| Funder | Health Technology Assessment Programme |
- Submission date
- 03/03/2020
- Registration date
- 13/05/2020
- Last edited
- 16/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
A humeral shaft fracture is a break in the long bone of the upper arm. It occurs mainly in two groups of individuals; young men and older women, as their bones are more fragile. Currently, the most common treatment for these fractures is non-operative. About 70% of cases are treated using a cast for 2 weeks and then a brace until the bone begins to heal properly – although there is a large variation in treatments between and in hospitals. The risk of complications is low and the cost is also relatively low at £1,100. The disadvantages are that the patient is immobilised for a prolonged period and the cumbersome cast can lead to significant pain and discomfort in some patients. There is also a 20% chance that the break will not heal. This then requires surgery and involves additional costs of approximately £15,500. There appears to be a worldwide trend towards treating these fractures with surgery (rather than a cast and a brace), however, there is no high-quality evidence that this is indeed a better option. Various reviews of the current evidence have recognised the need for further trials. Surgery is the more expensive route, and has a higher risk of complication e.g. infection and nerve damage. However, there is a better chance of the bone healing successfully and the patient is likely to recover more quickly allowing them to regain their independence sooner. The aim of this study is to directly compare these two methods of treating fractures of the humeral shaft. The researchers want to find out whether arm function and quality of life in patients with this fracture is better with the more conservative cast-and-brace treatment, or with surgery. They also need to compare the cost-effectiveness of both approaches. They want to produce sound evidence to establish if the drawbacks of surgery are balanced by improved results and acceptable costs.
Who can participate?
Patients aged 18 over who have a broken upper arm
What does the study involve?
Participants will be randomly allocated to receive either surgical or non-surgical (a brace) treatment for their broken upper arm. The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon. Surgery will typically be followed by 2 weeks in a sling. Patients treated non-surgically will have a cast applied in the Emergency Department which they will use for 2 weeks. They will then change to a brace which is usually worn for a further 8-10 weeks. Both groups will be given a structured rehabilitation programme. The researchers will collect data with regards to pain, time off work and driving, and functionality for 12 months after treatment.
What are the possible benefits and risks of participating?
Both treatments are used across the NHS currently for this type of fracture and are not new or experimental. There is a small risk of complications for participants who have the operation, such as infection or prominent metalwork as there would be with any surgery, both of which might require further treatment. The main potential risk of the brace treatment is that in about 1 of every 5 patients the bones do not heal properly. If this happens your fracture may require further treatment, which could be an operation. Both treatments are used across the NHS so there is no specific advantage for taking part in the study.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
January 2020 to February 2025
Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme (NIHR HTA) (UK)
Who is the main contact?
Miss Hannah Crook
hush@ndorms.ox.ac.uk
Contact information
Scientific
Oxford Trauma Kadoorie Centre
Level 3 John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 227912 |
|---|---|
| hush@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The HUmeral SHaft fracture trial (HUSH): a multi-centre prospective randomised superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older |
| Study acronym | HUSH |
| Study objectives | The aim of this pragmatic randomised controlled trial is to evaluate the clinical and cost-effectiveness of functional bracing, compared to surgical fixation for the treatment of humeral shaft fractures in patients over the age of 18. |
| Ethics approval(s) | Approved 02/06/2020, East of England - Cambridge Central Research Ethics Committee (Royal Standard Place Nottingham NG1 6FS, UK; +44 (0)207 104 8388; cambridgecentral.rec@hra.nhs.uk), ref: 20/EE/0127 |
| Health condition(s) or problem(s) studied | Humeral shaft fracture |
| Intervention | Participants will be randomised (online using RRAMP) in a 1:1 ratio stratified by centre; whether they are aged under 50 or 50 and over and whether they had a nerve injury at presentation or not, to either surgery or a brace. They will be randomised to be treated surgically or non-surgically. The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon. Surgery will typically be followed by 2 weeks in a sling. Patients treated non-surgically will have a cast applied in the Emergency Department which they will use for 2 weeks. They will then change to a brace which is usually worn for a further 8-10 weeks. Both groups will be given a structured rehabilitation programme. The trial will last for 12 months. Patients will be followed up at 6 months and 12 months after their injury. They will be asked about their quality of life, daily activities, pain, physiotherapy treatment and any complications. The researchers will also look at the resources and services they have used to determine the costs involved in both treatments. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Function measured using the Disabilities of Arms Shoulders and Hand (DASH) patient-reported outcome questionnaire at 12 months |
| Key secondary outcome measure(s) |
1. Function assessed using the Disabilities of Arms Shoulders and Hand (DASH) at baseline, 8 weeks, 3 and 6 months |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 334 |
| Total final enrolment | 334 |
| Key inclusion criteria | 1. Adult patients aged 18 years and older with a fracture of the humeral shaft (diaphysis) 2. Fracture of the humeral diaphysis which the surgeon believes may benefit from surgical fixation. ‘Diaphysis’ defined as the section of bone outside 1 Muller-square of the proximal and distal ends of the humerus (Müller 1990) 3. Participant is willing and able to give informed consent for participation in the study 4. Male or female, aged 18 years or above |
| Key exclusion criteria | 1. The fracture is open 2. The fracture is complicated by local tumour deposits 3. The index injury occurred more than 16 days prior to recruitment 4. The patient is unable to adhere to trial procedures 5. Other upper limb injuries which may reasonably be expected to affect responses to outcome PROMs |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 17/11/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date; please contact hush@ndorms.ox.ac.uk for more information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/04/2024 | 03/12/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | version 3.0 | 16/05/2025 | 16/05/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN17108318 HUSH_SAP_V3.0_16May2025_AuthorsRedacted.pdf
- Statistical Analysis Plan
Editorial Notes
16/05/2025: The statistical analysis plan was uploaded as an additional file.
03/12/2024: The following changes were made:
1. The recruitment end date was changed from 17/11/2023 to 17/11/2024.
2. A contact was updated.
3. Publication reference added.
22/11/2023: The following changes were made:
1. The recruitment end date was changed from 31/05/2022 to 17/11/2023.
2. The total final enrolment was added.
3. The overall study end date was changed from 30/11/2023 to 28/02/2025.
4. The intention to publish date was changed from 01/11/2024 to 28/02/2026.
29/07/2020: The ethics approval was added.
03/03/2020: Trial's existence confirmed by the NIHR.
