Comparison of surgical procedures for patients with a fracture of the wrist

ISRCTN	ISRCTN11980540
DOI	https://doi.org/10.1186/ISRCTN11980540
Protocol serial number	N/A
Sponsor	University of Oxford (UK)
Funder	Health Technology Assessment Programme

Submission date: 02/08/2016
Registration date: 03/08/2016
Last edited: 12/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
All adult patients with a broken wrist (fracture of the distal radius) are given a temporary wrist support and referred to the local fracture service for treatment. Most broken wrists can be treated without the need for surgery. However, for the more serious wrist injuries, the treating surgeon may recommend an operation to restore the normal position of the wrist bones. This study is comparing two different ways of holding the broken bones in the best position while they heal. They are both used routinely throughout the NHS, but the most effective technique is unknown. The first technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. The second technique involves the surgical fixation of the bone fragments using metal wires (K-wires). The aim of this study is to find out whether surgical fixation of the broken bones of the wrist is more effective than plaster cast treatment.

Who can participate?
Patients aged 16 years and over who are having surgery to treat a broken wrist.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have a plaster cast shaped (moulded) over the skin to hold the bone fragments in position. The cast remains in place for around 4-6 weeks. Those in the second group undergo surgical fixation of the bone fragments using metal wires (K-wires). During this surgery smooth wires with a sharp point are passed across the fracture site through the skin to hold the bone fragments in position while they heal. A plaster cast is applied over the top of the wires to hold the wrist joint still, but the cast does not have to be moulded into position as the wires themselves hold the bone in place. The surgical and research team assess all patients, look at an x-ray and make a record of any early complications at 6 weeks, according to standard clinical procedure. Patients are also asked to report their own recovery using a questionnaire at 3 months, 6 months and 12 months after the treatment. The questionnaire also asks about the patient s wrist function, their general quality of life and any costs they have incurred related to their injury.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for participants taking part in this study.

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

When is the study starting and how long is it expected to run for?
July 2016 to August 2020

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Marta Campolier, drafft2@ndorms.ox.ac.uk

Contact information

Dr Marta Campolier
Scientific

Nuffield Department Of Orthopaedics
Rheumatology and Muscoloskeletal Sciences
University of Oxford
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 227912
Email	drafft2@ndorms.ox.ac.uk

Ms Bojana Selinsek
Scientific

Nuffield Department Of Orthopaedics
Rheumatology and Muscoloskeletal Sciences
University of Oxford
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 227912
Email	drafft2@ndorms.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomized parallel trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Distal Radius Acute Fracture Fixation Trial 2
Study acronym	DRAFFT2
Study objectives	Null 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 plaster cast fixation versus K-wire fixation. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/152701
Ethics approval(s)	South Central - Oxford B Research Ethics Committee, 06/10/2016, ref: 16/SC/0462
Health condition(s) or problem(s) studied	Dorsally displaced fracture of the distal radius
Intervention	Participants are randomised to one of two groups, stratified by centre, intra-articular extension of the fracture and age of the patient (above or below 50 years). K-wire Fixation group: 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. Plaster Cast group: This technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. The plaster cast will remain in situ for 4-6 weeks. The study follow-up will range from events and at activities at the routine 6 week follow-up appointment. During this appointment radiographs and a short questionnaire on complications. This complications questionnaire will be completed by the Research Associate. The study follow-up will also require patients to complete questionnaires for Patient Rated Wrist Evaluation, EuroQolEQ-5D, complications and resource use at 3, 6 and 12 months post-operatively.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Wrist function is measured using the Patient Rated Wrist Evaluation (PWRE) at baseline, 3, 6 and 12 months post-operatively.
Key secondary outcome measure(s)	1. Quality of life is measured using the EQ-5D at Baseline, 3, 6 and 12 months post-operatively. 2. Complications are measured using a questionnaire filled in by either a research associate at 6 weeks. In addition, complications will also be measured using a questionnaire completed by the patient at 3, 6 and 12 months post-operatively. 3.Radiographic evaluation will be used to assess the quality of reduction at baseline, 6 weeks and 12 months after the injury 4. 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.
Completion date	31/08/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	476
Total final enrolment	890
Key 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. Aged of 16 and able to give informed consent. 3. The treating Consultant Surgeon believes that they would benefit from manipulation of the fracture.
Key exclusion criteria	1. Injury is more than two weeks old 2. Fracture extends more than 3 cm from radio carpal joint 3. Fracture is open with a Gustillo grading greater than 4. Articular surface of the fracture (specifically the radio-carpal joint) 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. 5. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment
Date of first enrolment	31/10/2016
Date of final enrolment	05/04/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

John Radcliffe Hospital

Oxford Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		19/01/2022	27/10/2022	Yes	No
Results article		01/02/2022	27/10/2022	Yes	No
Protocol article	protocol	23/03/2019	09/04/2020	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Radiographic analysis	13/02/2024	12/09/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	Statistical and health economic analysis plan	11/06/2020	12/09/2024	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/06/2024: Publication references added.
27/10/2022: Publication references added.
09/04/2020: Publication reference added.
31/03/2020: The following changes were made to the trial record:
1. The primary contact was changed.
2. The plain English summary was updated to reflect these changes.
09/05/2019: The following changes have been made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 05/04/2019.
2. The overall trial end date was changed from 31/07/2020 to 31/08/2020.
3. The intention to publish date was changed from 31/07/2020 to 31/10/2020.
4. The total final enrolment number was added.
11/12/2018: The following changes have been made:
1. The recruitment end date has been updated from 30/11/2018 to 30/04/2019.
2. The overall trial end date has been updated from 31/10/2019 to 31/07/2020.
3. The intention to publish has been updated from 31/10/2019 to 31/07/2020.
30/05/2018: The following changes have been made:
1. The study design has been changed from "Multi-centre double-blind randomised parallel trial" to "Multi-centre randomised parallel trial".
2. The recruitment end date has been changed from 31/05/2018 to 30/11/2018.
04/09/2017: The study contact phone numbers have been changed from +44 1865 227226 & +44 1865 227903 to +44 1865 227912.
01/09/2017: Ethics approval has been added. Dr Katy Mironov and Dr Shakil Patel have been removed as the study contact. Dr Robin Lerner and Bojana Selinsek have been added as study contacts.