Clinical study of the volar locking plate for distal radial fractures

ISRCTN	ISRCTN27396017
DOI	https://doi.org/10.1186/ISRCTN27396017
Protocol serial number	07OR003
Sponsor	Nottingham University Hospitals NHS Trust (UK)
Funders	Nottingham University Hospitals NHS Trust (UK), Nottingham University Hospitals Charity via the Hand Research Fund (UK)

Submission date: 17/05/2009
Registration date: 08/09/2009
Last edited: 07/10/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Alexia Karantana
Scientific

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

Study information

Primary study design	Interventional
Study design	Pragmatic randomised single centre controlled parallel group surgical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Unstable fractures of the distal radius: a randomised prospective clinical study comparing their treatment with volar locking plate and conventional method
Study objectives	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(s)	North Nottinghamshire Research Ethics Committee approved on the 6th September 2007 (ref: 07/H0407/39)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	122
Key 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
Key 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
Date of first enrolment	11/02/2008
Date of final enrolment	30/08/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Department of Orthopaedic & Accident Surgery

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/10/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes