Condition category
Injury, Occupational Diseases, Poisoning
Date applied
26/02/2018
Date assigned
06/03/2018
Last edited
06/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 August 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Matthew Northgraves
2. Hemant Sharma

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1513084

Contact information

Type

Scientific

Primary contact

Mr Matthew Northgraves

ORCID ID

Contact details

York Trials Unit
Department of Health Sciences
ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom

Type

Scientific

Additional contact

Mr Hemant Sharma

ORCID ID

Contact details

Department of Trauma and Orthopaedics
Hull and East Yorkshire NHS Hospitals Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36103; HTA 15/130/84

Study information

Scientific title

External frame versus internal locking plate for articular pilon fracture fixation: a multi-centre randomised controlled trial

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

Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 13/02/2018, ref: 18/YH/0014

Study design

Randomised; Both; Design type: Treatment, Surgery, Rehabilitation, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2017

Overall trial end date

31/08/2022

Reason abandoned

Eligibility

Participant 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 334; UK Sample Size: 334

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

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary (lead centre)
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust

Sponsor details

Research and Development Department
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/130/84

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 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).

Intention to publish date

31/08/2023

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes