ANZCTR - Registration

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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]

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

Wrist Fracture

Condition category

Condition code

Surgery

Other surgery

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

Treatment: Surgery

Intervention code [2]

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]

Function (Patient Rated Wrist Evaluation)

Timepoint [1]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [1]

Pain (VAS)

Timepoint [1]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [2]

Range of Movement using a standard wrist goniometer

Timepoint [2]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [3]

Complications (revision rate, tendon irritation, removal of plate, hardware failure) - medical chart and patient self-report

Timepoint [3]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [4]

Satisfaction using a 10 cm visual analogue scale

Timepoint [4]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [5]

Grip Strength using a Jamar Hand Grip Dynamometer in Kg Force

Timepoint [5]

2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [6]

Radiological (XRays) - alignment, tilt, variance, residual radial translation, union

Timepoint [6]

Baseline (pre-op), 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [7]

Quality of Life using the EQ5D Health Quality of Life Questionnaire

Timepoint [7]

Baseline (pre-op), 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively

Secondary outcome [8]

Disability/Function (QuickDASH)

Timepoint [8]

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?

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]

Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Queen Elizabeth II Hospital

Address [1]

Cnr Kessels, Troughton Road
Coopers Plains QLD 4108

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Princess Alexandra Hospital

Address [2]

199 Ipswich Road
Woolloongabba QLD 4102

Country [2]

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]

Hospital

Name [1]

QueenElizabeth II Hospital

Address [1]

Cnr Kessels, Troughton Road
Coopers Plains QLD 4108

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Princess Alexandra Hospital

Address [2]

199 Ipswich Road,
Woolloongabba, QLD, 4102

Country [2]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Brisbane Hand and Upper Limb Research Institute

Address [1]

Level 9 Specialist Centre, Brisbane Private Hospital, 259 Wickham Tce, Brisbane, Qld, 4000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Centres for Health Research
Metro South Hospital and Health Service 
Level 7 TRI, 37 Kent Street WOOLLOONGABBA QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/08/2012

Ethics approval number [1]

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]

/AnzctrAttachments/363006-Couzens et al_DistalRadius_2014.pdf (Publication)

Contacts

Principal investigator

Name

Prof Mark Ross

Address

Brisbane Hand and Upper Limb Research Institute
9/259 Wickham Terrace
Brisbane QLD 4000

Country

Australia

Phone

+61 7 3834 7069

Fax

[email protected]

Contact person for public queries

Name

Ruby Strauss

Address

9/259 Wickham Terrace
Brisbane, QLD 4000

Country

Australia

Phone

+61 7 3834 7069

Fax

[email protected]

Contact person for scientific queries

Name

Ruby Strauss

Address

9/259 Wickham Terrace
Brisbane Queensland 4000

Country

Australia

Phone

+61 7 3834 7069

Fax

[email protected]

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.	Type	Citation	Email
2569	Study protocol	Couzens 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	[email protected]
2570	Informed consent form		[email protected]
2571	Ethical approval		[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: A randomised clinical trial.	2014	https://dx.doi.org/10.1186/1471-2474-15-74

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added automatically