Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000969864
Ethics application status
Approved
Date submitted
7/09/2012
Date registered
10/09/2012
Date last updated
2/03/2021
Date data sharing statement initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a multi-centre randomised trial.
Scientific title
Clinical and radiological outcomes of stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures in adults
Secondary ID [1] 281187 0
Nil
Universal Trial Number (UTN)
U1111-1134-4166
Trial acronym
DRAD001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Radius Fractures 287363 0
Wrist Fracture 287366 0
Condition category
Condition code
Surgery 287693 287693 0 0
Other surgery
Musculoskeletal 287696 287696 0 0
Other muscular and skeletal disorders
Injuries and Accidents 287705 287705 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention A: Early surgical intervention using a Titanium volar locking plate. The plate is applied during surgery to provide internal fixation to a distal radius fracture. The approximate duration of the surgical procedure is 2 hours. Early active rehabilitation is commenced at 1-2 days following the surgery and the fracture is protected in a splint for up to 6 weeks.
Intervention code [1] 285647 0
Treatment: Surgery
Intervention code [2] 285653 0
Treatment: Devices
Comparator / control treatment
Intervention B: Early surgical intervention using a Stainless Steel volar locking plate. The plate is applied during surgery to provide internal fixation to a distal radius fracture. The approximate duration of the surgical procedure is 2 hours. Early active rehabilitation is commenced at 1-2 days following the surgery and the fracture is protected in a splint for up to 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287942 0
Function (Patient Rated Wrist Evaluation)
Timepoint [1] 287942 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [1] 299090 0
Pain (VAS)
Timepoint [1] 299090 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [2] 299091 0
Range of Movement using a standard wrist goniometer
Timepoint [2] 299091 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [3] 299092 0
Complications (revision rate, tendon irritation, removal of plate, hardware failure) - medical chart and patient self-report
Timepoint [3] 299092 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [4] 299093 0
Satisfaction using a 10 cm visual analogue scale
Timepoint [4] 299093 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [5] 299094 0
Grip Strength using a Jamar Hand Grip Dynamometer in Kg Force
Timepoint [5] 299094 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [6] 299095 0
Radiological (XRays) - alignment, tilt, variance, residual radial translation, union
Timepoint [6] 299095 0
Baseline (pre-op), 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [7] 299096 0
Quality of Life using the EQ5D Health Quality of Life Questionnaire
Timepoint [7] 299096 0
Baseline (pre-op), 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively
Secondary outcome [8] 299097 0
Disability/Function (QuickDASH)
Timepoint [8] 299097 0
2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Eligibility
Key inclusion criteria
Aged 18 years and over
Acute distal radius fracture requiring surgery as diagnosed on X-Ray or CT scan
Presentation within 3 weeks of injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of previous wrist fracture, injury or surgery with ongoing symptoms or functional limitation
Significant acute associated fracture or trauma to the ipsilateral upper limb
Associated significant injuries increasing the risk of surgery or preventing compliance with rehabilitation
Distal radius fractures that are unable to be adequately fixated with a volar plate
Medical or anaesthetic contraindications to surgery
Unable to comply with rehabilitation or attend follow-up appointments up to two years post surgery
Currently pregnant
Unable to provide written informed consent

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)
All patients presenting to the emergency departments or orthopaedic outpatient clinics of the trial sites with distal radius fractures will be assessed for inclusion in the study. Eligible patients invited to participate. Consenting patients will complete baseline assessments conducted by a hand therapist or orthopaedic surgeon prior to group allocation. Allocation will be performed by the orthopaedic surgeon booking the surgery after the baseline assessments have been completed using concealed, opaque envelopes containing a randomly generated allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients providing written informed consent for participation in this trial will be randomly assigned to either early intervention group (titianium or stainless steel volar multi-axial locking plates).The randomisation sequence will be computer generated and concealed in sequentially numbered sealed, opaque envelopes by a person, not otherwise associated with this research. Each envelope will contain a sheet of paper with the words either “TITANIUM” or “STAINLESS STEEL”.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Rehabilitation will commence within 2 days of surgery and be performed by occupational therapists who have training in hand therapy. A standard post-operative therapy protocol will be followed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study Design
Randomised Clinical Trial with two intervention groups.

Statistical Methods
Baseline demographic and clinical data will be reported using descriptive statistics and tabulated (e.g. Students t-test for continuous variables and Pearson chi-square for categorical variables). Between group differences in baseline data will be examined using unpaired conventional tests of hypothesis (such as unpaired t-tests) depending on the nature of the data. Between group and within group differences in outcome measures over time will be examined using a priori unpaired and paired conventional tests of hypothesis (such as Analysis of Variance with simple effects examined using t-tests) depending on the nature of the data. Bonferroni adjustments for multiple comparisons will be made where appropriate to mitigate risk of type-1 error. The complication rates will be reported in terms of frequency. The frequencies of complications will be compared using statistical analysis such as the Pearson chi-square statistic.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/09/2012
Actual
14/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
108
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11478 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 285963 0
Hospital
Name [1] 285963 0
Queen Elizabeth II Hospital
Country [1] 285963 0
Australia
Funding source category [2] 285964 0
Hospital
Name [2] 285964 0
Princess Alexandra Hospital
Country [2] 285964 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Metro South Health Division, Brisbane
199 Ipswich Road
Woolloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 284786 0
Hospital
Name [1] 284786 0
QueenElizabeth II Hospital
Address [1] 284786 0
Cnr Kessels, Troughton Road
Coopers Plains QLD 4108
Country [1] 284786 0
Australia
Secondary sponsor category [2] 284788 0
Hospital
Name [2] 284788 0
Princess Alexandra Hospital
Address [2] 284788 0
199 Ipswich Road,
Woolloongabba, QLD, 4102
Country [2] 284788 0
Australia
Other collaborator category [1] 280256 0
Charities/Societies/Foundations
Name [1] 280256 0
Brisbane Hand and Upper Limb Research Institute
Address [1] 280256 0
Level 9 Specialist Centre, Brisbane Private Hospital, 259 Wickham Tce, Brisbane, Qld, 4000
Country [1] 280256 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287998 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 287998 0
Centres for Health Research
Metro South Hospital and Health Service
Level 7 TRI, 37 Kent Street WOOLLOONGABBA QLD 4102
Ethics committee country [1] 287998 0
Australia
Date submitted for ethics approval [1] 287998 0
Approval date [1] 287998 0
07/08/2012
Ethics approval number [1] 287998 0
HREC/12/QPAH/293

Summary
Brief summary
Distal radius fractures are among the most common fractures seen in the hospital emergency department. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating systems have better clinical
and radiological outcomes following surgery, and also the lowest complication rates. Few studies have compared
different types of plates, which may have different plate and screw designs, features or may be manufactured from
different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the
clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of
distal radius fractures: one made from stainless steel (Trimed Volar Plate) and the other made from titanium (Medartis Volar Plate).



This study will use a two group (intervention) blinded (blinded outcome assessor, blinded data analysis, concealed randomisation, blinded participant) randomised trial in an
adult population.

A suite of outcome measures recommended for this patient group will be used. These measures include an assessment of range of movement, strength, function (quickDASH and Patient Rated Wrist Evaluation), pain(VAS) , complications (medical chart and self-report), quality of life (EQ5D),
radiological outcome (XRay) and patient
satisfaction (VAS). These outcomes will be administered by a blinded assessor at seven time points: baseline, 2
weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Trial website
Trial related presentations / publications
Couzens G, Peters S, Cutbush K, Hope B, Taylor F, James C, Rankin C, Ross M. Stainless steel versus titanium multi-axial locking plates for fixation of distal radius fractures: A randomized clinical trial. BMC Musculoskelet Disord. 2014 Mar 11;15:74. doi: 10.1186/1471-2474-15-74.
Public notes
Attachments [1] 2904 2904 0 0
/AnzctrAttachments/363006-Couzens et al_DistalRadius_2014.pdf (Publication)

Contacts
Principal investigator
Name 34684 0
Prof Mark Ross
Address 34684 0
Brisbane Hand and Upper Limb Research Institute
9/259 Wickham Terrace
Brisbane QLD 4000
Country 34684 0
Australia
Phone 34684 0
+61 7 3834 7069
Fax 34684 0
Email 34684 0
research@upperlimb.com
Contact person for public queries
Name 17931 0
Ms Ruby Strauss
Address 17931 0
9/259 Wickham Terrace
Brisbane, QLD 4000
Country 17931 0
Australia
Phone 17931 0
+61 7 3834 7069
Fax 17931 0
Email 17931 0
research@upperlimb.com
Contact person for scientific queries
Name 8859 0
Ms Ruby Strauss
Address 8859 0
9/259 Wickham Terrace
Brisbane Queensland 4000
Country 8859 0
Australia
Phone 8859 0
+61 7 3834 7069
Fax 8859 0
Email 8859 0
research@upperlimb.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from participants who have given permission to share their data for research projects.
Names will be removed, dates of birth will be converted to ages and individual identifiers will be removed rendering the data non-identifiable
When will data be available (start and end dates)?
The start date of IPD availability will be 1/12/2024 with no end-date.
Available to whom?
Available to researchers with Ethics-approved projects (must provide protocol and evidence of approval).
Available for what types of analyses?
Available for analysis for any research with Ethics approval.
How or where can data be obtained?
We intend to share the data in med.data.edu.au.
Licensing will be discussed with med.data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2569Study protocolCouzens GB, Peters SE, Cutbush K, et al. Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial. BMC Musculoskelet Disord. 2014;15:74. Published 2014 Mar 11. doi:10.1186/1471-2474-15-74 research@upperlimb.com
2570Informed consent form  research@upperlimb.com
2571Ethical approval  research@upperlimb.com


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: A randomised clinical trial.2014https://dx.doi.org/10.1186/1471-2474-15-74
N.B. These documents automatically identified may not have been verified by the study sponsor.