Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/01/2013
Date assigned
10/01/2013
Last edited
21/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The tibia (shinbone or shankbone) is the most commonly broken major bone in the leg. Injuries usually require hospital admission, frequently require surgery and result in prolonged periods (months) away from work and social activities. The treatment of displaced, extra-articular fractures of the distal tibia (lower third) remains controversial. These injuries are difficult to manage due to the limited soft tissue cover, poor vascularity of the area and proximity of the fracture to the ankle joint. Infections, non-union and malunion are well-recognised complications. The aim of this study is to find out whether there is a clinical and cost-effectiveness difference between two techniques for the operative fixation of fractures of the distal tibia: locking-plate fixation and intramedullary nail fixation.

Who can participate?
All patients aged 16 years or over presenting at the trial centres with an isolated, acute fracture of the distal tibia are potentially eligible to take part in the trial.

What does the study involve?
Participants will be randomly allocated to either intramedullary nailing or locking-plate fixation. Both of these operations are widely used within the NHS and all of the surgeons in the chosen centres will be familiar with both techniques. A research associate will perform a clinical assessment and make a record of any early complications at 6 weeks after the operation and an x-ray will be taken. A further clinical assessment and x-ray will also be taken at 12 months after the operation to detect late complications. Participants will complete questionnaires at 3 months, 6 months and 12 months after the operation.

What are the possible benefits and risks of participating?
The patient may benefit from internal fixation of the fracture. The risks associated with this study are predominantly the risks associated with the surgery: infection, bleeding and damage to the adjacent structures such as nerves, blood vessels and tendons. Participants in both groups will undergo surgery and will potentially be at risk from any/all of these complications. There is no data to suggest that the risk is greater in one group or another. We believe that the overall risk profile is similar for the two interventions but assessment of the number of complications in each group is a secondary objective of this trial.

Where is the study run from?
The University of Warwick in collaboration with University Hospitals Coventry and Warwickshire NHS Trust.

When is the study starting and how long is it expected to run for?
March 2013 to February 2017.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Professor Matthew Costa
matthew.costa@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthew Costa

ORCID ID

Contact details

Warwick Clinical Trials Unit
Division of Health Sciences
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 (0)24 7615 1721
matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/136/04, Version 2.0

Study information

Scientific title

UK FixDT - A Randomised Controlled Trial for patients with a displaced fracture of the distal tibia, is there a clinical and cost-effectiveness difference between 'locking' plate fixation and intramedullary nail fixation

Acronym

UK FixDT

Study hypothesis

Null hypothesis: There is no difference in the Disability Rating Index (DRI) at 6 months after injury between adults with a displaced fracture of the distal tibia treated with 'locking'-plate fixation versus intramedullary nail fixation.

Ethics approval

NRES Committee West Midlands - Coventry & Warwickshire, 06/11/2012, REC ref: 12/WM/0340

Study design

Multi-centre randomised clinical trial

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 below to request a patient information sheet

Condition

Distal Tibia Fractures / Injuries & Accidents

Intervention

Comparing two techniques for the operative fixation of fractures of the distal tibia.

Intramedullary nailing
The intramedullary nail is inserted at the proximal end of the tibia and passed down the centre of the bone in order to hold the fracture in the correct (anatomical) position. The reduction technique, the surgical approach, the type and size of the nail, the configuration of the proximal and distal inter-locking screws and any supplementary device or technique will be left entirely to the discretion of the surgeon as per standard clinical practice.

'Locking' 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. Again, 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 - this is standard practice with all distal tibia 'locking' plates.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

To quantify and draw inferences on observed differences in the Disability Rating Index between the trial treatment groups at 6 months after injury

Secondary outcome measures

1. To quantify and draw inferences on observed differences early functional status at 3 months and later functional status at 12 months
2.To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening
3. To identify any differences in health-related quality of life between the trial treatment groups in the first year after the injury. EQ-5D; The EQ-5D is a validated, generic health-related quality of life measure consisting of 5 dimensions each with a 3-level answer possibility. Each combination of answers can be converted into a health utility score. It has good test-retest reliability, is simple for patients to use, and gives a single preference-based index value for health status that can be used for broader cost-effectiveness comparative purposes.
4. To determine the complication rate of intramedullary nail fixation versus 'locking'-plate fixation in the first year after the injury. all complications will be recorded, including malunion, delayed/non-union, infection, wound complications, vascular and neurological injury and venous thrombo-embolism. A record will also be kept of any other surgery required in relation to the index fracture, including removal of any metalwork.
5. To investigate, using appropriate statistical and economic analytical methods, the resource use, costs and comparative cost effectiveness of intramedullary nail fixation versus 'locking'-plate fixation

Olerud and Molander (OMAS) is a self-administered patient questionnaire. It is a good outcome tool for assessing symptoms after an ankle fracture. The score is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The scoring system correlates well with parameters considered to summarise the results after this type of injury and is therefore recommended for use in scientific investigations.

Overall trial start date

01/03/2013

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years or over, either sex
2. Any fracture which involves the distal tibial metaphysis - defined as a fracture extending within 2 Muller squares of the ankle joint
3. In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum of 320

Participant exclusion criteria

Current exclusion criteria as of 03/02/2014:
1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
2. The fracture is open
3. There is a contra-indication to anaesthesia
4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires

Previous exclusion criteria:
1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
2. The fracture is open with a Gustillo grade of more than 1
3. There is a contra-indication to anaesthesia
4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires

Recruitment start date

01/03/2013

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Research Support Services
University House
Coventry
CV4 7AL
United Kingdom
+44 (0)24 7652 3716
p.a.hedges@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/136/04

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26384729

Publication citations

Additional files

Editorial Notes