Condition category
Musculoskeletal Diseases
Date applied
14/05/2014
Date assigned
14/05/2014
Last edited
14/02/2017
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
+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 measures

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

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

14/02/2017: No publications found in PubMed, verifying study status with principal investigator.