Mr Simon John Pickard
Distal Radius Internal Fixation Trial version 1, 1 May 2010
The Distal Radius Internal Fixation Trial is a multi-centre, randomised controlled trial assessing the functional benefit/value for money of fixation of low-impact wrist fractures using a volar plate compared to K wiring. The primary outcome is participants functional score 6 months post surgery using the Disability of Arm, Shoulder and Hand questionnaire. Patient diaries will provide a qualitative insight. The costs/benefits of both interventions will be evaluated for utilisation of health resources and from a societal perspective; a cost per unit of effect will be determined.
Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
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)
Primary outcome measures
Disability of Arm Shoulder and Hand Questionnaire functional score at 6 months post surgery; Timepoint(s): 3months, 6months and 12months post surgery
Secondary outcome measures
1. EQ5D Questionnaire; Timepoint(s): Baseline (before surgery) 3months, 6months and 12 months post surgery
2. Patient Diary; Timepoint(s): To be completed during the 3 months post surgery
3. Patient Related Wrist Evaluation Questionnaire functional score; Timepoint(s): 3months, 6months and 12months post surgery
4. Resource Usage Questionnaire; Timepoint(s): 3months, 6months, 9months and 12months post surgery
5. X-ray review; Timepoint(s): 3months and 12months post surgery
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Planned Sample Size: 169; UK Sample Size: 169
Participant 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.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0408-16214
Funding Body Type
Funding Body Subtype
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