Comparing a nail placed within the fibula (calf bone) to plates and screws in surgical stabilisation of unstable ankle fractures in adults
| ISRCTN | ISRCTN54687269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54687269 |
| IRAS number | 88616 |
| Secondary identifying numbers | IRAS 88616 |
- Submission date
- 13/03/2020
- Registration date
- 14/04/2020
- Last edited
- 15/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Orthopaedic Trauma Service
Royal Infirmary of Edinburgh
Edinburgh
EH9 4SU
United Kingdom
 ORCID ID |
0000-0002-6125-7112 |
|---|---|
| Phone | +44 (0)131 242 3435 |
| twhite@rcsed.ac.uk |
Study information
| Study design | Randomized controlled two-centre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN54687269_PIS_v4_17Aug2009.pdf |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 04/05/2010 |
| Completion date | 10/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 125 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/09/2011 |
| Date of final enrolment | 24/02/2013 |
Locations
Countries of recruitment
- Denmark
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH16 4SU
United Kingdom
2650
Denmark
Sponsor information
University/education
Royal Infirmary of Edinburgh
Edinburgh
EH16 4SU
Scotland
United Kingdom
| Phone | +44 (0)131 242 1000 |
|---|---|
| enquiries@accord.sco | |
| Website | http://www.nhslothian.scot.nhs.uk/Pages/default.aspx |
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | For publication in a prominent orthopaedic journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v4 | 17/08/2009 | 15/05/2020 | No | Yes |
Additional files
- ISRCTN54687269_PIS_v4_17Aug2009.pdf
- uploaded 15/05/2020
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.
