Condition category
Musculoskeletal Diseases
Date applied
14/05/2014
Date assigned
14/05/2014
Last edited
14/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon John Pickard

ORCID ID

Contact details

Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
simon.pickard@rjah.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9191

Study information

Scientific title

Acronym

Distal Radius Internal Fixation Trial version 1, 1 May 2010

Study hypothesis

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.

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 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

01/10/2010

Overall trial end date

16/12/2013

Reason abandoned

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

Sponsor information

Organisation

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust(UK)

Sponsor details

Twmpath Lane
Oswestry
SY10 7AG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes