External frame versus internal locking plate for articular pilon fracture fixation
| ISRCTN | ISRCTN98152560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98152560 |
| IRAS number | 224065 |
| Secondary identifying numbers | CPMS 36103, HTA 15/130/84, IRAS 224065 |
- Submission date
- 26/02/2018
- Registration date
- 06/03/2018
- Last edited
- 01/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
A pilon fracture is a severe break of the shin bone where it forms the ankle joint. It is usually caused by a high-energy impact such as a fall from a height. These injuries are very difficult to treat, and can have a very large negative effect on a person’s quality of life. Surgery is needed to fix the broken bone, which can lead to serious infections, meaning more treatment is needed, including on occasion amputation. Even where the fracture heals well, most patients develop arthritis in the joint. The injury is usually fixed by orthopaedic surgeons from the inside (under the skin) using a plate and screws (internal fixation) or fixed from the outside using a ring frame or cage (external fixation). The internal plate is cheaper than the external ring but the internal plate may increase the chance of the patient getting a deep infection. There is genuine uncertainty among surgeons as to which is the preferred surgical option. National Institute for Health and Care Excellence and Consultant Orthopaedic Surgeons have recommended that high-quality research is needed to find out whether internal or external fixation is best for treating pilon fractures and which is the better use of NHS money. This study aims to investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of Type C pilon fractures.
Who can participate?
Patients aged 16 or older with a closed type C pilon fracture of the tibia
What does the study involve?
Participants are randomly allocated to undergo either internal plate fixation or external fine wire fixation. All participants receive standardised, written physiotherapy advice detailing the exercises they need to perform for rehabilitation following their injury. They are advised to move their toes, ankle and knee joints fully within the limits of their comfort. Early weight-bearing is encouraged, but the details are decided by the treating surgeon. Any other rehabilitation input including and beyond written physiotherapy advice (such as formal referral to physiotherapy) is left to the discretion of the treating clinicians. The participants’ own ratings of their disability are collected at 3, 6, 12 and 24 months follow-up.
What are the possible benefits and risks of participating?
As there is uncertainty regarding which treatment is best, there is no specific benefit to the participants other than the potential to inform future clinical practice and to help future patients decide which treatment is best for them. Both study treatments are used in routine NHS practice, so no new risks are anticipated beyond those that are already associated with the treatments used.
Where is the study run from?
Hull Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
September 2017 to April 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Stephen Brealey
2. Hemant Sharma
Contact information
Scientific
York Trials Unit
Department of Health Sciences
ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0001-9749-7014 |
|---|---|
| Phone | +44 1904 321357 |
| Stephen.Brealey@york.ac.uk |
Scientific
Department of Trauma and Orthopaedics
Hull and East Yorkshire NHS Hospitals Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
| hemant.sharma5@nhs.net |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | External frame versus internal locking plate for articular pilon fracture fixation: a multi-centre randomised controlled trial |
| Study acronym | ACTIVE |
| Study hypothesis | This study aims to investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of Type C pilon fractures. |
| Ethics approval(s) |
1. Approved 13/02/2018, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (Jarrow Business Centre, Jarrow, NE32 3DT, United Kingdom; +44 (0)207 104 8081; bradfordleeds.rec@hra.nhs.uk), ref: 18/YH/0014 2. Approved 02/03/2022, University of Cape Town, Faculty of Health Sciences, HREC (E53-Room 46, Old Main Building, Groote Schurr Hospital, Cape Town, Observatory 7925, South Africa; None available; hrec-enquiries@uct.ac.za), ref: 700/2021 3. Approved 23/04/2021, Sydney Local Health District Research Ethics and Governance Office (Research Ethics and Governance Office, Royal Prince Alfred Hospital, Camperdown, NSW 2050, Australia; +61 020 9515 7035; SLDH-RPAEthics@health.nsw.gov.au), ref: X21-0041 & 2020/ETH02046 |
| Condition | Injuries to the knee and lower leg |
| Intervention | Participants will be randomly allocated into one of two techniques for the operative fixation of closed type C pilon fractures: Internal plate fixation The ‘locking’ plate is inserted at the distal end of the tibia and passed under the skin on the surface of the bone. The details of the reduction technique, the surgical approach, the type and position of the plate, the number and configuration of fixed-angle screws and any supplementary device or technique will be left to the discretion of the surgeon. The only stipulation is that fixed angle screws must be used in at least some of the distal screw holes as this is standard practice with all distal tibia ‘locking’ plates. External frame fixation A limited minimally invasive open reduction and fixation of articular segment is undertaken. Once the articular segment is stabilized, the circular fixator is applied to the bone. Incision site, number and configuration of screws, number of rings, wires and half pins will depend on the fracture configuration and will be left at the discretion of the surgeon. Occasionally, synthetic/iliac crest bone grafts may be necessary and circular fixator will have to extend across the ankle, which again will be left at the discretion of surgeon. Post-surgery rehabilitation All patients randomised into the two groups will receive standardised, written physiotherapy advice detailing the exercises they need to perform for rehabilitation following their injury. Patients in both groups will be advised to move their toes, ankle and knee joints fully within the limits of their comfort. Early weight-bearing will be encouraged, but the details of weight-bearing status will be decided by the treating surgeon. In this pragmatic trial, any other rehabilitation input including and beyond written physiotherapy advice (such as formal referral to physiotherapy) will be left to the discretion of the treating clinicians. Patient reported outcome measures at baseline, 3, 6, 12 and 24 months after randomisation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Patient's own rating of their disability specifically related to the lower limb, assessed using the Disability Rating Index (DRI) at baseline, 3, 6, 12 and 24 months follow-up post-randomisation. The DRI is a validated patient-reported outcome measure questionnaire. It consists of a 12-item Visual Analogue Scale questionnaire. The DRI has been proven to be a robust, practical clinical and research instrument with good responsiveness and acceptability for assessment of disability caused by impairment in the lower limb. The baseline assessment will ask participants about their functioning before their injury and before their surgery. Twelve months after randomisation has been chosen to be the primary endpoint to allow the interventions and co treatment interventions to be delivered and the majority of complications to be treated. |
| Secondary outcome measures | 1. Olerud and Molander Ankle Score (OMAS) collected at baseline, 3, 6, 12 and 24 months follow-up 2. Patient health related quality of life, assessed using the EQ5D-5L generic and health economic self-complete patient-reported outcome measure. This will be collected twice at baseline: i.e. once to assess patient health related quality of life on the day (after the injury) and once with regard to patient health related quality of life during the week before injury; then once each at 3, 6, 12 and 24 months 3. Complications: Data on all further surgical procedures and other complications, e.g. deep wound infection (using Centres for Disease Control and Prevention definition), superficial infection, pin site infection (defined using the ‘Good, Bad and Ugly’ pin site grading system), rehospitalisation, blood clots, wound dehiscence, septic arthritis, secondary interventions for non-union and all other secondary procedures will be collected at 3, 6, 12 and 24 months 4. Non-union, mal-union and secondary arthritis. Non-union will be defined as inability to heal as confirmed on x rays/CT scan or as secondary intervention for failure to heal. Mal-union is defined by a standard measurement based on Dror Paley's technique, undertaken using final radiographs at 12 months. Secondary arthritis in the ankle will be assessed using the Kellgren and Laurence scale 5. Resource use and work impact: Data on resource use and work impact will be collected to inform the economic evaluation (e.g. length of hospital stay, rehospitalisation and return to work). This data will be gathered at 3, 6, 12 and 24 months 6. Patient preference for treatment: Data on patient preferences will be collected at baseline and 12 months 7. Transition question: To assist interpretation of findings, patients will be asked at the 12-month follow-up time-point whether compared with when they initially sustained the pilon fracture one year previously, how their ankle is currently |
| Overall study start date | 01/09/2017 |
| Overall study end date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Total final enrolment | 255 |
| Participant inclusion criteria | Current inclusion criteria as of 05/03/2019: 1. Patients aged 16 years or older 2. With a closed intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). This includes patients with a bi-lateral pilon fracture and who have polytrauma. 3. Where the treating surgeon believes the patient will benefit from surgical fixation Previous inclusion criteria: 1. Patients aged 16 years or older 2. With a closed unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). Only unilateral fractures are included since problems may occur in rehabilitation with bilateral fractures which may compromise outcomes 3. Where the treating surgeon believes the patient will benefit from surgical fixation |
| Participant exclusion criteria | 1. More than 21 days since injury 2. Previous failed fixation 3. Pathologic fracture 4. Pre-existing (pre-injury) skin condition which precludes open surgery 5. Patient is/would be unable to understand instructions for treatment |
| Recruitment start date | 09/03/2018 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- Australia
- England
- Northern Ireland
- Scotland
- South Africa
- United Kingdom
- Wales
Study participating centres
HU3 2JZ
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Liverpool
L7 8XP
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Whitechapel Road
London
E1 1BB
United Kingdom
Truro
TR1 3LQ
United Kingdom
Poole
BH15 2JB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Sheffield
S5 7AU
United Kingdom
TS4 3BW
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Reading
RG1 5AN
United Kingdom
Oswestry
SY10 7AG
United Kingdom
Norwich
NR4 7UY
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Southampton
SO16 6YD
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Taunton
TA1 5DA
United Kingdom
Swansea
SA12 7BR
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Leeds
LS1 3EX
United Kingdom
SE5 9RS
United Kingdom
LE1 5WW
United Kingdom
W2 1NY
United Kingdom
G51 4TF
United Kingdom
G4 0SF
United Kingdom
DE22 3NE
United Kingdom
AB25 2ZN
United Kingdom
DL3 6HX
United Kingdom
BT47 6SB
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Cape Town
SA 7925
South Africa
Kogarah
Sydney
NSW 2217
Australia
Caringbah
Sydney
NSW 2229
Australia
Liverpool
Sydney
NSW 2170
Australia
Murdoch
Perth
WA 6150
Australia
New Lambton Heights
Sydney
NSW 2305
Australia
Sponsor information
Hospital/treatment centre
Research and Development Department
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
England
United Kingdom
"ROR" |
https://ror.org/01b11x021 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Additional documentation will be added to the NIHR website when available: https://www.journalslibrary.nihr.ac.uk/programmes/hta/1513084/#/ The trialists plan to disseminate trial results to key stakeholders and patients in several ways: 1. The study protocol will be published in a peer-reviewed, open access journal 2. A HTA research monograph will be produced 3. In conjunction with patient members of the team they will generate patient information for “Shared Decision Making” based on findings from this trial and update the entry on Wikipedia and write the Map of Medicine entry on pilon fractures management 4. The results of the study will be presented at national and international surgical meetings such as the British Orthopaedic Association Annual Congress, the UK Orthopaedic Trauma Society meeting, the North American Orthopaedic Trauma Association the European Federation of National Associations of Orthopaedics and Traumatology (EFFORT), Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT and the American Academy of Orthopaedic Surgeons 5. The findings will be published in peer reviewed high impact general medical and orthopaedic journals such as Lancet, the BMJ or similar 6. A summary of the study report, written in lay language will be produced and made available to participants, members of the user group and relevant patient-focused websites A full dissemination strategy will be produced for the trial. |
| IPD sharing plan | Current IPD Sharing statement as of 01/07/2020: The datasets generated during and/or analysed during the current study are/will be available upon request. Trial participants give informed consent that the information collected about them will be used to support other research in the future and may be shared anonymously with other researchers. All the individual participant data collected during the trial, after identification and the study protocol, SAP, informed consent form and CRFs with variables names will be available. Other documents can be requested for consideration from the team. This data will be made available immediately following the main publication of the clinical effectiveness and cost-effectiveness findings with no end date. Requests may be made by researchers who provide a methodologically sound proposal for any purpose/analysis. Proposals should be directed to the Chief Investigator at hksorth@yahoo.co.uk and will be reviewed by the trial team. To gain access, data requestors will need to complete a data request form provided by York Trials Unit and sign a data confidentiality agreement as stipulated in the trial team’s publication plan. Previous IPD Sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Ms Ada Keding, trial statistician (Ada.Keding@york.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2021 | 16/03/2021 | Yes | No |
| Interim results article | Recruitment optimisation study | 17/06/2021 | 19/07/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/10/2024: Ethics approvals for South Africa and Australia were added.
10/11/2023: The following changes were made:
1. Research Ethics Committee contact information was added.
2. The total final enrolment was added.
02/10/2023: The following changes were made to the trial record:
1. The contacts were updated.
2. The overall end date was changed from 30/04/2025 to 31/10/2024.
3. The intention to publish date was changed from 30/04/2026 to 31/10/2025.
30/08/2023: The following changes were made to the trial record:
1. The IRAS number was added.
2. The target number of participants was changed from 334 to 250.
3. The countries of recruitment Australia and South Africa were added.
4. The study participating centres University Hospitals Coventry & Warwickshire NHS Trust, Groote Schuur Hospital, St George Hospital, The Sutherland Hospital, Liverpool Hospital, Fiona Stanley Hospital, John Hunter Hospital were added.
5. The intention to publish date was changed from 31/08/2023 to 30/04/2026.
22/10/2021: Internal review.
19/07/2021: Publication reference added.
17/03/2021: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2021 to 31/10/2023.
2. The overall trial end date has been changed from 31/08/2022 to 30/04/2025 and the plain English summary has been updated accordingly.
3. The protocol version number has been changed from "v1.2 2018.11.30" to "v3.0 21/01/2020"
16/03/2021: Publication reference added.
27/10/2020: Recruitment for this study is no longer paused as of 07/07/2020.
02/07/2020: The IPD Sharing statement has been updated.
19/05/2020: Trial participating centres added: John Radcliffe Hospital, Royal Liverpool University Hospital, St Georges University Hospitals NHS Foundation Trust, The Royal London Hospital, Royal Cornwall Hospitals NHS Trust, Poole Hospital NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Royal Stoke University Hospital, Royal Berkshire NHS Foundation Trust, Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Norfolk and Norwich University Hospital NHS Foundation Trust, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Queen Elizabeth Hospital, Taunton and Somerset NHS Foundation Trust, Morriston Hospital, Wythenshawe Hospital, Leeds General Infirmary, King's College NHS Foundation Trust, University Hospitals Leicester NHS Foundation Trust, Imperial College Healthcare NHS Trust, Queen Elizabeth University Hospital, Glasgow Royal Infirmary, Royal Derby Hospital, Aberdeen Royal Infirmary, Durham and Darlington NHS Trust, Altnagelvin Area Hospital.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
27/03/2019: The condition has been changed from "Specialty: Injuries and emergencies, Primary sub-specialty: Musculoskeletal Trauma; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the knee and lower leg, Injuries and Accidents/ Injuries to the ankle and foot" to "Injuries to the knee and lower leg" following a request from the NIHR.
07/03/2019: Internal review.
06/03/2019: A scientific contact was added
05/03/2019: The following changes were made to the trial record:
1. The plain English summary was updated.
2. The inclusion criteria were updated.
3. The protocol number was added.
