Distal Radius Internal Fixation Trial

ISRCTN	ISRCTN07813725
DOI	https://doi.org/10.1186/ISRCTN07813725
Protocol serial number	9191
Sponsor	The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)
Funder	NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0408-16214

Submission date: 14/05/2014
Registration date: 14/05/2014
Last edited: 19/02/2020

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Simon John Pickard
Scientific

Twmpath Lane
Oswestry
SY10 7AG
United Kingdom

Phone	+44 1691 404226
Email	simon.pickard@rjah.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Surgical interventions for treating intra and extra-articular distal radius fractures: a randomised controlled trial of internal fixation with plate & screws versus percutaneous K-wiring
Study acronym	Distal Radius Internal Fixation Trial
Study objectives	The aim of this study is to assess the functional benefit/value for money of fixation of low-impact wrist fractures using a volar plate compared to K wiring.
Ethics approval(s)	10/H1203/19
Health condition(s) or problem(s) studied	Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention	K-wires, The number of K-wires used and whether they are buried or not depends on the surgeon's preference.; Volar plate, The volar approach and a fixed angled locking plate should be used for patients in the plate treatment group.; Follow Up Length: 12 month(s)
Intervention type	Other
Primary outcome measure(s)	Disability of Arm Shoulder and Hand Questionnaire functional score at baseline, 3, 6 and 12 months
Key secondary outcome measure(s)	1. EQ5D Questionnaire at baseline, 3, 6 and 12 months 2. Patient Diary kept for three most post-surgery 3. Patient Related Wrist Evaluation Questionnaire functional score at baseline 3, 6 and 12 months 4. Resource Usage Questionnaire at baseline, 3, 6 and 12 months 5. X-ray review at 3 and 12 months
Completion date	16/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	169
Total final enrolment	170
Key inclusion criteria	1. The patient is skeletally mature (at least 16 years old). 2. The patient has had a low-impact trauma resulting in an isolated distal radius fracture as confirmed by Xray. Lowimpact fractures are those sustained in a fall from no higher than a standing position and at a velocity not above that of running. 3. The fracture is no more than 2 weeks old at the time of surgery. 4. There is no definite contraindication to, or definite indication for, one particular intervention and thus the surgeon is uncertain as to whether to treat the fracture with a plate or with kwiring. 5. NonEnglish speaking patients may be entered if there is a translator present at the time of consent and they have someone to help them fill in the questionnaires
Key exclusion criteria	1. The patient has not given informed consent. 2. The patient is a child under 16 years of age. 3. The patient is not medically fit for surgery. 4. The fracture has previously been treated. 5. There is major displacement of articular fragments or obvious ligament injury. 6. The fracture is not displaced or is minimally displaced so that conservative treatment rather than surgery is considered appropriate. 7. If the fracture is accompanied by a compound injury with a Gustillo grading of 2 or higher. 8. The patient is unlikely to or unable, due to a cognitive impairment (as defined by the medical team responsible, this includes drug/alcohol abuse), to provide consent and complete questionnaires. 9. If the patient is not able to complete a year of followup Patients not eligible for the study will receive clinical care and treatment as they would per normal clinical practice.
Date of first enrolment	01/10/2010
Date of final enrolment	16/12/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Twmpath Lane

Oswestry
SY10 7AG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/02/2020: The following changes have been made:
1. A results abstract link has been added to publication and dissemination plan.
2. The final enrolment number has been added from the abstract.
14/02/2017: No publications found in PubMed, verifying study status with principal investigator.