Condition category
Musculoskeletal Diseases
Date applied
17/05/2009
Date assigned
08/09/2009
Last edited
07/10/2013
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

Miss Alexia Karantana

ORCID ID

Contact details

Academic Department of Orthopaedic & Accident Surgery
West Block C Floor
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07OR003

Study information

Scientific title

Unstable fractures of the distal radius: a randomised prospective clinical study comparing their treatment with volar locking plate and conventional method

Acronym

Study hypothesis

This study will compare the outcome of displaced distal radial fractures when treated with a volar locking plate (the Distal Volar Radius [DVR®]) or the conventional method which involves percutaneous wires +/- an external fixator.

Our primary research objective is to determine whether the use of volar locking plates improves functional outcome and allows for an earlier return to normal activities and work.

As a secondary objective, we aim to determine through economic evaluation, whether the use of volar locking plates for distal radial fractures is of financial benefit to the health service and society in general.

Ethics approval

North Nottinghamshire Research Ethics Committee approved on the 6th September 2007 (ref: 07/H0407/39)

Study design

Pragmatic randomised single centre controlled parallel group surgical trial

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

Distal radius fracture

Intervention

The intervention consists of surgical fixation of the distal radius fracture in a patient who fulfils the trial inclusion and exclusion criteria with a radial volar locking plate or the established conventional method involving percutaneous wires +/- an external fixator.

The health technology under assessment is the radial volar locking plate, a type of orthopaedic implant with locking screws which aid the reduction and stabilisation of distal radius fractures. We compare this to the established conventional methods (percutaneous wires and/or an external fixator device).

The plate chosen for this trial is the Distal Volar Radius or DVR® plate, which is in common use across the United Kingdom. Instrumentation also includes smooth 1.6 mm Kirschner wires and the standard AO external fixator, as appropriate. All are currently in use within the NHS, CME licensed and will not require MHRA authorisation.

The total duration of follow-up for each participant is one year post-surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Function of the limb following a surgically treated distal radius fracture. As a measure of function we selected the Hand Health Profile forming part of the Patient Evaluation Measure (PEM). Expected duration of patient participation will be one year. Follow up and data collection will be performed at 6 weeks, 12 weeks and 1 year.

Secondary outcome measures

1. Clinical measurements: grip strength and range of motion
2. Radiographic parameters: radial length, palmar tilt, radial inclination and articular gaps/steps less or equal to 2 mm
3. Quality of life: as assessed via the EUROQUOL EQ-5D and 12-item short form health survey (SF-12) scores

Expected duration of patient participation will be one year. Follow up and data collection will be performed at 6 weeks, 12 weeks and 1 year.

Overall trial start date

11/02/2008

Overall trial end date

30/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fractures which the referring physician considers require operative intervention
2. Configuration is such that the fracture would be amenable to stabilisation via volar locking plate (not massively comminuted)
3. Adults (skeletally mature) with high demand requirements of their wrist in whom the radiological appearance of the bone suggests that it is robust enough to tolerate internal fixation; and in whom the fracture pattern at presentation fulfils the criteria as described below
4. Fractures of the distal radius which are:
4.1. Dorsally displaced extra-articular fractures (with or without an undisplaced intra-articular component) with dorsal cortical comminution as seen on the lateral radiograph
4.2. Displaced intra-articular fractures with an articular step or gap in the radio-carpal joint surface
5. Skeletally mature adults, minimum age 16 years and above, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

122

Participant exclusion criteria

1. Patients with concomitant systemic diseases (diabetes with vascular or neurological complications, advanced cardiac, pulmonary or neurological disease)
2. Proximal metaphyseal fractures (more than one inch or 2.5 centimetres from the articular surface)
3. Open fractures
4. Smith's and volar Barton's configuration
5. Previous fractures of the distal radius of the same or contra-lateral limb less than six months old
6. Significant pre-existing radiological abnormality
7. Multiply injured
8. Bilateral injuries
9. Patients who are unable to consent for themselves to treatment
10. Patients who may have difficulties in adequate understanding of English

Recruitment start date

11/02/2008

Recruitment end date

30/08/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Orthopaedic & Accident Surgery
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
E11 Curie Court
Nottingham University Hospitals
Queens Campus
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Government

Website

http://www.nuh.nhs.uk/nch/randd/

Funders

Funder type

Government

Funder name

Nottingham University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nottingham University Hospitals Charity via the Hand Research Fund (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24088965

Publication citations

  1. Results

    Karantana A, Downing ND, Forward DP, Hatton M, Taylor AM, Scammell BE, Moran CG, Davis TR, Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods: a randomized controlled trial., J Bone Joint Surg Am, 2013, 95, 19, 1737-1744, doi: 10.2106/JBJS.L.00232.

Additional files

Editorial Notes