Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000323628
Ethics application status
Approved
Date submitted
11/03/2014
Date registered
26/03/2014
Date last updated
26/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fractures of the distal radius: a randomized controlled trial of 180 patients comparing volar locking plates and traditional surgical treatment
Scientific title
In treating patients with distal radius fractures, do volar locking plates produce better outcomes than traditional surgical treatment when assessed by DASH score primarily with function and radiological assessment as secondary outcomes.
Secondary ID [1] 284237 0
Nil
Universal Trial Number (UTN)
U1111-1154-3526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture of the distal radius 291349 0
Condition category
Condition code
Surgery 291712 291712 0 0
Surgical techniques
Injuries and Accidents 291773 291773 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volar locking plate fixation of distal radius fracture. Surgery involves a volar approach to the distal radius and fixation with a plate which utilises locking screw heads. This is designed to provide a stable construct, supporting the chondral surface and allowing early mobilisation. Surgery takes about an hour.
Intervention code [1] 288944 0
Treatment: Surgery
Intervention code [2] 288945 0
Treatment: Devices
Comparator / control treatment
Surgical treatment of distal radius fractures other than Volar Locking Plate, including Kirschner wires, non-locking plates and external fixateur. Choice of which surgical procedure in this group is at the discretion of the treating physician but excludes Volar Locking Plate.
Control group
Active

Outcomes
Primary outcome [1] 291654 0
DASH score
Timepoint [1] 291654 0
One week post surgery, 12 weeks, 52 weeks.
Secondary outcome [1] 307238 0
Range of motion of the affected wrist, both actual range and as a percentage of the unaffected wrist motion, measured with a goniometer placed at the axis of wrist motion and measured in three planes.
Timepoint [1] 307238 0
One, 6, 12, 52 weeks after surgery
Secondary outcome [2] 307239 0
Grip strength measured with a Jamar Dynamometer and averaged over three readings, recorded in kilograms and expressed as a percentage of the uninjured side.
Timepoint [2] 307239 0
One, 6, 12, 52 weeks post operation.
Secondary outcome [3] 307240 0
Radiological measurement, radial length, angle, inclination and step
Timepoint [3] 307240 0
Initial, in theatre, one, 6, 12 weeks post operation.

Eligibility
Key inclusion criteria
Patients with a distal radius fracture requiring surgical fixation, over 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive incapacity, neurological disorders affecting coordination or function, pre-existing upper limb deformity or disability and concurrent upper limb injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation from table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2005
Actual
13/08/2005
Date of last participant enrolment
Anticipated
24/04/2009
Actual
24/04/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2181 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 7859 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 288865 0
Self funded/Unfunded
Name [1] 288865 0
Peter Tamblyn
Country [1] 288865 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Bedford Drive
Bedford Park,,
South Australia 5042
Country
Australia
Secondary sponsor category [1] 287561 0
None
Name [1] 287561 0
Address [1] 287561 0
Country [1] 287561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290694 0
Flinders Medical Centre Ethics Committee
Ethics committee address [1] 290694 0
Bedford Drive,
Bedford Park,
South Australia 5042
Ethics committee country [1] 290694 0
Australia
Date submitted for ethics approval [1] 290694 0
Approval date [1] 290694 0
11/07/2005
Ethics approval number [1] 290694 0

Summary
Brief summary
Fractures of the distal radius,: a randomised controlled trial comparing the volar locking plate and routine current surgical treatment
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 46842 0
Dr Peter Tamblyn
Address 46842 0
Department of Orthopaedic Surgery,
Bedford Drive,
Flinders Medical Centre,
Bedford Park,
South Australia 5042
Country 46842 0
Australia
Phone 46842 0
+618 82044289
Fax 46842 0
Email 46842 0
[email protected]
Contact person for public queries
Name 46843 0
Dr Peter Tamblyn
Address 46843 0
Department of Orthopaedic Surgery,
Bedford Drive,
Flinders Medical Centre,
Bedford Park,
South Australia 5042
Country 46843 0
Australia
Phone 46843 0
+618 82044289
Fax 46843 0
Email 46843 0
[email protected]
Contact person for scientific queries
Name 46844 0
Dr Peter Tamblyn
Address 46844 0
Department of Orthopaedic Surgery,
Bedford Drive,
Flinders Medical Centre,
Bedford Park,
South Australia 5042
Country 46844 0
Australia
Phone 46844 0
+618 82044289
Fax 46844 0
Email 46844 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.