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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24088965
Publication citations
-
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.