Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/03/2010
Date assigned
29/03/2010
Last edited
21/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fractures of the wrist are extremely common injuries. If the broken bones have stayed in their original place, then the fracture can usually be treated in a plaster cast or splint. However, some 'unstable' fractures (where the broken bones have been displaced) might need to be fixed back into place with an operation. The two most commonly used techniques in the UK are fixation with wires inserted through the skin (a simple and well-established method), and fixation with a plate which is applied to the surface of the bone with special screws (a very modern, potentially advantageous but expensive method). The aim of this study is to compare these two techniques.

Who can participate?
Patients aged over 18 with a wrist fracture

What does the study involve?
Participants are randomly allocated to be treated with either the wire fixation or the plate fixation technique. Before the operation and at three occasions after the operation (3 months, 6 months and 1 year), the patients' wrist function and quality of life are assessed. X-rays are taken at 6 weeks and 1 year to check if healing has occurred. A record is kept of any complications which occur after the operation. The patients are also asked to provide information about any out-of-pocket expenses they might have had in the period after the operation as a result of the injury (for instance whether they had to see a physiotherapist or had a cleaner for a while). The results of all these measurements are then used in two ways: to determine if there is a difference in effectiveness of the two fixation methods and what the most cost-effective method is, bearing in mind the quality of life of the patients.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Warwick (UK)

When is the study starting and how long is it expected to run for?
July 2010 to December 2013

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

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

Trial website

http://www.warwick.ac.uk/go/drafft

Contact information

Type

Scientific

Primary contact

Mr Matthew Costa

ORCID ID

Contact details

Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 968 618
Matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/116/97

Study information

Scientific title

A randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a displaced fracture of the distal radius

Acronym

DRAFFT

Study hypothesis

There is no difference in the Patient Rated Wrist Evaluation score (PRWE) one year post-injury between adult patients with a dorsally displaced fracture of the distal radius treated with locking-plate fixation versus K-wire fixation.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0811697
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0012/52041/PRO-08-116-97.pdf

Ethics approval

Coventry Research Ethics Committee, 24/02/2010, ref: 10/H1210/10

Study design

Multicentre randomised double-blind 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

Dorsally displaced fracture of the distal radius

Intervention

K-wire Fixation:
The wires are passed through the skin over the dorsal aspect of the distal radius and into the bone in order to hold the fracture in the correct (anatomical) position. The size and number of wires, the insertion technique and the configuration of wires will be left entirely to the discretion of the surgeon. A plaster cast will be applied at the end of the procedure to supplement the wire fixation as per standard surgical practice. This cast holds the wrist still and is left on until the wires are removed at the follow-up appointment.

Volar locking plate:
The locking-plate is applied through an incision over the volar (palm) aspect of the wrist. Again, the details of the surgical approach, the type of plate, and the number and configuration of screws will be left to the discretion of the surgeon. The screws in the distal portion of the bone will be fixed-angle, i.e. screwed into the plate, but this is standard technique for the use of these plates. The type of proximal screw will be left to the discretion of the surgeon; these may be locking or non-locking screws as the bone in this area provides a much better purchase for the screws. Some surgeons use a temporary plaster cast to hold the patientsÂ’ wrist still but the fixed-angle stability provided by the locking-plate is generally sufficient to allow early controlled range-of-movement exercises. The use or otherwise of a cast will again be left to the discretion of the surgeon as per usual practice.

The treatment takes approximately 1 hour. All patients will be followed-up for 12 months.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Primary outcome measure as of 24/01/2012:
Patient Rated Wrist Evaluation (PWRE). The PRWE score is a validated questionnaire which is self-reported (filled out by the patient). It consists of 15 items specifically related to the function of the wrist. This data will be collected at baseline, 3, 6 and 12 months post-operatively. The PRWE is the most sensitive outcome measure for patients sustaining this specific injury. Analysis will be performed on the complete data set as well as on the subgroup of patients over the age of 50 years.

Previous primary outcome measure:
Patient Rated Wrist Evaluation (PWRE). The PRWE score is a validated questionnaire which is self-reported (filled out by the patient). It consists of 15 items specifically related to the function of the wrist. This data will be collected at baseline, 3, 6 and 12 months post-operatively. The PRWE is the most sensitive outcome measure for patients sustaining this specific injury.

Secondary outcome measures

1. Disabilities of Arm, Shoulder and Hand score (DASH) - the DASH Outcome Measure is a 30-item, self-report questionnaire designed to provide a more general measure of physical function and symptoms in people with musculoskeletal disorders of the upper limb
2. EQ-5D - a validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score.
3. Complications - all complications will be recorded
4. Radiographic evaluation - standard posterior-anterior and lateral radiographs will be taken at baseline, 6 weeks and 12 months after the injury. These radiographs are those routinely used for the investigation of patients with a suspected fracture of the distal radius and for the follow-up of such patients following any intervention, so there will be no need to request any additional or special investigations. Although the technique for taking these radiographs is well-established, each centre will be provided with a written protocol to ensure that exactly the same views are obtained at each hospital. An assessment of the quality of the reduction, and the risk of subsequent loss of reduction, will be made using the criteria recommended by Mackenney et al.
5. Resource use will be monitored for the economic analysis. Unit cost data will be obtained from national databases such as the BNF and PSSRU Costs of Health and Social Care. Where these are not available the unit cost will be estimated in consultation with the UHCW finance department. The cost consequences following discharge, including NHS costs and patients' out-of-pocket expenses will be recorded via a short questionnaire which will be administered at 3, 6 and 12 months post surgery. Patient self-reported information on service use has been shown to be accurate in terms of the intensity of use of different services.

Overall trial start date

01/07/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3 cm of the radio-carpal joint
2. The treating Consultant Surgeon believes that they would benefit from operative fixation of the fracture
3. Aged over 18 years (either sex) and able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum of 390

Participant exclusion criteria

1. The fracture extends more than 3 cm from radio-carpal joint
2. The fracture is open with a Gustillo grading greater than 1
3. The articular surface of the fracture cannot be reduced by indirect techniques (in a small number of fractures, the joint surface is so badly disrupted that the surgeon will have to open up the fracture in order to restore the anatomy under direct vision)
4. There are contra-indications to surgery, defined as:
4.1. Severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction
4.2. Severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission
4.3. Any other systemic medical condition that would produce a specific contraindication to a general anaesthetic
5. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment or intravenous drug abuse

Recruitment start date

01/07/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Sciences Research Institute
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Dr Peter Hedges
Research Support Services
University House
Coventry
CV4 8UW
United Kingdom
+44 (0)2476 523 859
p.a.hedges@warwick.ac.uk

Sponsor type

University/education

Website

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

Organisation

University Hospitals Coventry and Warwickshire NHS Trust (UK)

Sponsor details

c/o Mrs Ceri Jones
University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21914196
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25096595
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25716883

Publication citations

  1. Protocol

    Costa ML, Achten J, Parsons NR, Rangan A, Edlin RP, Brown J, Lamb SE, UK DRAFFT - a randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius., BMC Musculoskelet Disord, 2011, 12, 201, doi: 10.1186/1471-2474-12-201.

  2. Results

    Costa ML, Achten J, Parsons NR, Rangan A, Griffin D, Tubeuf S, Lamb SE, , Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial., BMJ, 2014, 349, g4807.

  3. Results

    Costa ML, Achten J, Plant C, Parsons NR, Rangan A, Tubeuf S, Yu G, Lamb SE, UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius, Health Technol Assess, 2015, 19, 17, 1-124, doi: 10.3310/hta19170.

Additional files

Editorial Notes

21/04/2016: Plain English summary added. On 24/01/2012 the target number of participants was changed from 390 to a minimum of 390.