Condition category
Surgery
Date applied
13/03/2020
Date assigned
14/04/2020
Last edited
15/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Unstable ankle fractures are most commonly managed with surgery using plates and screws. There can be complications related principally to wound healing and infection, and prominent metalwork. In patients with poor skin condition, such as those aged over 65, and diabetics, an alternative device, the fibular nail, has been shown to achieve reduction and stability with a lower rate of such complications. The aim of this study was to compare the outcome of fibular nail with plate fixation for unstable fractures of the ankle in a younger cohort of patients.

Background and study aims
Ankle fractures are common injuries. When the fracture is unstable it requires surgery, and the most common way to fix the bones is with plates and screws. There can be problems from the wound and the plate. In this study, the investigators aimed to compare this established technique with a newer alternative: the use of a fibular nail which avoids both potential problems.

Who can participate?
Adult patients with unstable ankle fractures

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will have standard fixation surgery using plates and screws. The other will have fixation surgery using the fibular nail.

What are the possible benefits and risks of participating?
Participants in the fibular nail group may have a lower rate of wound- and metalwork-related complications. They will, however, still have an operation and therefore there will inevitably still be a small risk of surgical and anaesthetic complications.

Where is the study run from?
Royal Infirmary of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
May 2010 to March 2015

Who is funding the study?
Scottish Orthopaedic Research Trust - into trauma (SORT-it) (UK)

Who is the main contact?
Mr Tim White, tim.white@nhslothian.scot.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tim White

ORCID ID

http://orcid.org/0000-0002-6125-7112

Contact details

Orthopaedic Trauma Service
Royal Infirmary of Edinburgh
Edinburgh
EH9 4SU
United Kingdom
+44 (0)131 242 3435
twhite@rcsed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 88616

Study information

Scientific title

A prospective, randomised, controlled, multicentre, international trial comparing the fibular nail with open reduction and internal fixation for unstable ankle fractures in younger patients

Acronym

Study hypothesis

There is no difference in outcome, as measured by Olerud and Mollander Ankle Score at 1 year, between standard open reduction and internal fixation, and fibular nailing, of unstable ankle fractures. This is an extension of a study examining outcomes using the same procedure in elderly patients only (see https://pubmed.ncbi.nlm.nih.gov/27587528/ ).

Ethics approval

1. Initial study in elderly subjects approved 07/04/2005, Lothian Local Research Ethics Committee 02 (Deaconess House, 148 Pleasance, Edinburgh, EH8 9RS; +44 (0)131 536 9000; no email), ref: 05/S1102/02
2. Amended 07/11/2006, Lothian Local Research Ethics Committee 02 (Deaconess House, 148 Pleasance, Edinburgh, EH8 9RS; +44 (0)131 536 9000; lyndsay.baird@lhb.scot.nhs.uk), ref: 05/S1102/02
3. Amended to enable recruitment of younger participants 04/03/2010, NHS Lothian R&D Office (Room E1.12, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ; +44 (0)131 242 3330; R&DOffice@luht.scot.nhs.uk), ref: 05/S1102/02, 2010/R/OP/01
4. Approved, Danish Ethics Committee, ref: H-4-2011-141

Study design

Randomized controlled two-centre clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Surgical stabilisation of ankle fractures

Intervention

Participants were randomly allocated to the control or intervention arms using sealed opaque envelope allocation with a ratio of 1:1 in batches of 20.

Control: Open reduction and internal fixation was performed in the standard manner with plates and screws.

Intervention:Fibular nailing was performed according to the manufacturer’s instructions and the investigators' previously published technique (https://www.ncbi.nlm.nih.gov/pubmed/22844054 ).

Duration of treatment: Surgical procedure performed within a week of injury and surgery lasts around 1 h. Moon-boot orthosis worn for 6 weeks.

Follow-up: Clinical, functional and radiological assessments were carried out at 6 weeks, 3 months, 6 months, 1 year and 2 years post-randomisation. Complications and the need for further surgery was recorded at each visit. Complications were defined as superficial or deep wound infections, loss of fracture reduction, symptomatic metalwork requiring removal, onset of neurological symptoms and/or signs following surgery, and further surgery for any cause. Superficial infections were defined as an infection that resolved with antibiotics and required no surgical intervention. Deep infections were defined as requiring a return to theatre for surgical debridement with or without subsequent removal of metalwork. Late removal of symptomatic metalwork was performed for prominence, pain and discomfort at the patient’s request only.

Intervention type

Device

Phase

Not Applicable

Drug names

Acumed fibular nail

Primary outcome measure

Ankle symptoms after ankle fracture assessed using the Olerud-Molander Ankle Score core (OMAS) at 1 year

Secondary outcome measures

Complications assessed by follow-up examination at 6 weeks, 3 months, 6 months, 1 year and 2 years post-randomisation

Overall trial start date

04/05/2010

Overall trial end date

10/03/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 to <65 years
2. Unstable fracture of the ankle
3. Within 2 weeks of fracture
4. No ipsilateral injury to the lower limb

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

125

Participant exclusion criteria

1. Patients unable to give informed consent or those with cognitive impairment
2. Bilateral injuries or ipsilateral injury to the lower limb
3. Pilon fractures
4. Patients unable to comply with follow-up

Recruitment start date

18/09/2011

Recruitment end date

24/02/2013

Locations

Countries of recruitment

Denmark, United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
Little France
Edinburgh
EH16 4SU
United Kingdom

Trial participating centre

Hvidovre University Hospital
Copenhagen
2650
Denmark

Sponsor information

Organisation

NHS Lothian

Sponsor details

Royal Infirmary of Edinburgh
Edinburgh
EH16 4SU
United Kingdom
+44 (0)131 242 1000
enquiries@accord.sco

Sponsor type

University/education

Website

http://www.nhslothian.scot.nhs.uk/Pages/default.aspx

Funders

Funder type

Research organisation

Funder name

Scottish Orthopaedic Research Trust into Trauma (SORT-it)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

For publication in a prominent orthopaedic journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to conditions pertaining at the ethical approval stage.

Intention to publish date

01/08/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/05/2020: The participant information sheet was uploaded as an additional file. 06/04/2020: Trial's existence confirmed by Lothian Local Research Ethics Committee 02.