Contact information
Type
Scientific
Primary contact
Mr Simon John Pickard
ORCID ID
Contact details
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
+44 1691 404226
simon.pickard@rjah.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9191
Study information
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
Acronym
Distal Radius Internal Fixation Trial
Study hypothesis
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
10/H1203/19
Study design
Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative
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
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
Phase
Not Applicable
Drug names
Primary outcome measure
Disability of Arm Shoulder and Hand Questionnaire functional score at baseline, 3, 6 and 12 months
Secondary outcome measures
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
Overall trial start date
01/10/2010
Overall trial end date
16/12/2013
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
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
01/10/2010
Recruitment end date
16/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0408-16214
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
Basic results (scientific)
Publication list