Can we improve healing in broken shin bones by changing the settings on the surgical frame that is normally used to fix these injuries?
| ISRCTN | ISRCTN16465304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16465304 |
| IRAS number | 289401 |
| Secondary identifying numbers | IRAS 289401 |
- Submission date
- 06/04/2021
- Registration date
- 21/05/2021
- Last edited
- 21/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study is comparing two methods of fixing broken shin bones. Commonly doctors treat broken shin bones by attaching a frame to the outside of the leg which goes into the bone. This frame is fixed firmly in place, ensuring the broken bone cannot move as it heals. Recent research in animals suggests that better results could be achieved if the frame is kept slightly loose for the first few weeks, allowing for the bone to heal more before it is set firmly in place. This method has been used in humans safely, but so far no one has measured whether it is better or worse than the current treatment.
Who can participate
Adults (aged 18 or above) with broken shin bones
What does the study involve?
Patients who agree to take part in the trial will receive either the normal rigid frame, or a frame that is fixed marginally looser initially. Those with the more loose frame will have an x-ray after 2-3 weeks, and at that point they will have their frame tightened. Apart from this, all the patients will receive the normal level of care. Both frames should still allow the patients to walk on the leg as their pain eases. Patients will be seen regularly up until at least 1 year after your injury to see how they are getting on. They will also be asked to complete questionnaires about their experience.
What are the possible benefits and risks of participating?
This study will inform which treatment is the best for people with this potentially life-changing fracture. Participants will not benefit from this study but their contribution will help develop and guide the future treatment. The risks of receiving either treatment are the standard risks of receiving the surgery. The surgeon will be able to discuss the risks of the procedure in depth. The standard risks for any tibial fractures are pain, infection (<3%), delayed/non union (< 5%), malunion (<5%). Other risks from having surgery are blood clots, and damage to adjacent structures such as blood vessels, nerves or tendons. Some of these can cause serious or long-lasting problems.
Where is the study run from?
Hull University Teaching Hospitals (UK)
When is the study running and how long is it expected to run for?
March 2020 to April 2024
Who is funding the study
Investigator initiated and funded
Who is the main contact?
Mr Hemant Kumar Sharma, h.sharma@hull.ac.uk
Matthew Marples, Matthew.marples@nhs.net
Contact information
Scientific
Hull Royal Infirmary
Analby Road
Hull
HU3 2JZ
United Kingdom
 ORCID ID |
0000-0003-3781-1651 |
|---|---|
| Phone | +44 (0)1482875875 |
| h.sharma@hull.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN16465304_PIS_V4_14Mar21.docx |
| Scientific title | Assessment of bone healing time in tibial fractures; Static vs variable dynamization external fixation |
| Study acronym | B-VAST |
| Study objectives | Variable reverse dynamization external fixation for the treatment of tibial fractures will result in improved fracture healing times compared to the standard method of static external fixation. |
| Ethics approval(s) | Approved 01/04/2021, London - Queen Square Research Ethics Committee (HRA NRES Centre Bristol 3rd floor, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8061; queensquare.rec@hra.nhs.uk), REC ref: 21/LO/0181 |
| Health condition(s) or problem(s) studied | Adult patients with tibial fractures |
| Intervention | Patients will be randomly allocated to receive either the intervention (variable reverse dynamization external fixation) or the control (standard static external fixation). This randomisation will be done via computer software, the trial will not be blinded. Both treatments arms receive the same operation to fix the tibial fracture with an external fixator frame (which is standard practice). The difference between the two treatments is that in the reverse dynamisation group, the frame settings will be different (initially slightly looser, to allow small movements at the fracture site and encourage bone healing). Both groups of patients will still be able to mobilise as pain allows, no cast is required. At 2 - 3 weeks the patients in the reverse dynamization group will have an extra x-ray to show whether the bone has started to heal, at this point the frame settings will be altered to become rigid like in the other group. All other intervention in the trial will be standard care such as routine follow up, x-rays, and physiotherapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to bone healing, measured using the Radiographic union (RUST) score at 3, 6, 12 weeks and every following 6 weeks until radiographically united (RUST score 9 or above) |
| Secondary outcome measures | 1. Ankle function according to patient measured using Olerud and Molander Ankle score at baseline, 3, 6 and 12 months after frame removal 2. Health-related quality of life measured using EuroQol 5 Dimensions score at baseline, 3, 6 and 12 months after frame removal 3. Knee function according to patient measured using Oxford knee score at baseline, 3, 6 and 12 months after frame removal 4. Complications measured using case report forms and hospital records at 3, 6 and 12 months 5. Resource use and work impact measured using questionnaires and hospital records at 3, 6 and 12 months |
| Overall study start date | 20/03/2020 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patients 16 years or older 2. Isolated unilateral or bilateral 41A & B, 42A B&C and 43 A tibial fractures 3. Traverse fractures, short oblique, and fractures with single butterfly 4. Where the treating surgeon believes the patients will benefit from surgical stabilisation |
| Key exclusion criteria | 1. More the 28 days since fracture 2. Polytrauma - closed head injury, spinal fractures, pelvis/acetabular fractures, floating knee, femoral fractures, foot/ankle fractures or dislocations, knee dislocation or ligamentous injuries 3. Comminuted and segmental fractures 4. Previous failed fixation 5. Pathologic fracture 6. Patient is/would be unable to understand instructions for treatment 7. Patient declines consent to participate 8. Pregnant |
| Date of first enrolment | 30/05/2021 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Trauma and Orthopaedic department
Analby road
Hull
HU3 2JZ
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Great George street
Leeds
LS1 3EX
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
Daisy Building
Castle Hill Hospital
Hull
HU16 5JQ
England
United Kingdom
| Phone | +44 (0)1482875875 |
|---|---|
| James.Illingworth@hey.nhs.uk |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The results of the study will be presented at national and international surgical meetings and published in peer-reviewed medical and orthopaedic journals. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V4 | 14/03/2021 | 21/05/2021 | No | Yes |
| Protocol file | version V3 | 14/03/2021 | 21/05/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN16465304_PIS_V4_14Mar21.docx
- Uploaded 21/05/2021
- ISRCTN16465304_PROTOCOL_V3_14Mar21.docx
- Uploaded 21/05/2021
Editorial Notes
21/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2022 to 30/04/2023.
2. The overall trial end date has been changed from 30/07/2023 to 30/04/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/07/2023 to 31/12/2024.
14/06/2021: The acronym was changed from DynamiteX to B-VAST.
21/05/2021: Uploaded protocol Version 3, 14 March 2021 (not peer reviewed). The participant information sheet has been uploaded.
27/04/2021: Trial's existence confirmed by the Health Research Authority.
