ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616001590459

Ethics application status

Approved

Date submitted

31/10/2016

Date registered

17/11/2016

Date last updated

20/02/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

A study comparing 2 different systems for surgical fixation of broken wrists

Scientific title

Effects of the Austofix VRP2 system and the Depuy-Synthes LCP Distal Radius System on outcomes in adult patients undergoing surgery for distal radius fractures : a randomised controlled trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1189-1672

Trial acronym

POWIFF

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

distal radius fracture

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will have fixation with the Austofix VRP2 distal radius plate.
Surgery will take place at the routine time and in the routine manner, undertaken by any operating surgeon from the department (at all surgical levels). The VRP2 sytem is lower profile, has more variable locking options for the screws, and is universal (ie no left or right)

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

The control group will have fixation in the same overall environment, but using the Depuy-Synthes LCP distal radius plate system.

Control group

Active

Outcomes

Primary outcome [1]

PRWE Score - includes wrist pain and function

Timepoint [1]

6 weeks, 3 months, 12 months

Secondary outcome [1]

Complications - prospectively recorded at each clinic visit / phone interview.

Timepoint [1]

Up to 1 year

Secondary outcome [2]

Delayed union rates, recorded prospectively at clinic visits. Delayed union is defined as fracture not fully healed by 3 months, judged clinically and on radiographs.

Timepoint [2]

3 months

Secondary outcome [3]

Fracture reduction acheived at surgery and maintained at 1 year - measured against normal values on plain radiographs

Timepoint [3]

immediate post-op, and 1 year

Secondary outcome [4]

DASH Scores - disability / symptoms only

Timepoint [4]

6 weeks, 3 months, 1 year

Secondary outcome [5]

EQ5D - health status score

Timepoint [5]

3 months, 1 year

Secondary outcome [6]

Wrist Active ROM, as measured clinically - flexion/extension, rotation, abduction/adduction, compared to the opposite side. If this is not possible (eg pathology affecting opposite side) then standard ranges will be applied for the comparison.

Timepoint [6]

3 months, 1 year

Secondary outcome [7]

Time to resumption of work, recorded at clinic visits.

Timepoint [7]

6 weeks, 3 months, 1 year

Secondary outcome [8]

Operative time - from theatre operation record, time knife to skin to dressing applied.

Timepoint [8]

End of surgery

Secondary outcome [9]

Number of screws used - from operative records

Timepoint [9]

End of surgery

Secondary outcome [10]

Flouroscopy time - from operative records

Timepoint [10]

End of surgery

Secondary outcome [11]

Patient perceived percentage global return of function, recorded at clinic reviews as a simple question

Timepoint [11]

3 months, 12 months

Eligibility

Key inclusion criteria

1. Traumatic Distal radius fracture
2. Closed injury
4. Patient medically fit for surgery
5. Ability to be followed for up to 12 months
6. Presentation within 14 days of injury

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients with concomitant injuries affecting treatment and rehabilitation of the affected arm
2. Patients with associated neurovascular injuries requiring immediate surgery
3. Patients with associated significant carpal injuries, including scaphoid fractures
4. Patient unlikely or unhappy to attend for follow up
5. Patient with limited English proficiency
6. Patient without cognitive capacity to consent and participate
7. Patients with impaired upper limb function prior to injury enough to have a DASH score of more than 30 points.

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)

Yes - sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation.
Stratified by Age group (under or over 60), Gender, and surgical consultant

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Continuous data will be summarised as means with standard deviations and medians with range. Categorical measures will be summarized as percentages. Treatment effects will be assessed using a two way (treatment group by time) repeated measures analysis of variance (ANOVA) and/or a linear mixed effects model as required. Post hoc comparisons will be made using t-tests. An intention-to-treat and a per-protocol analysis will be considered. All tests will be two-tailed and assessed at the 5% alpha level.

Power calculations:
Sample size calculations were based on the requirement that effects be assessed at the 5% alpha level with 90% statistical power. It was assumed that the minimum clinically important difference on the PRWE is 11.5 points and the standard deviation would be 20 points. Under these assumptions, a sample of 65 patients per group would be required; following the application of a variance inflation factor of 1.5 to account for repeated measurements over time, a sample of 98 patients per group would be required.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

23/01/2017

Actual

1/03/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

196

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

North Terrace
Adelaide SA5000

Country [1]

Australia

Primary sponsor type

Individual

Name

Mark Rickman

Address

Level 4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC Royal Adelaide Hospital

Ethics committee address [1]

North Terrace
Adelaide SA5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/09/2016

Approval date [1]

27/10/2016

Ethics approval number [1]

R20160909 HREC/16/RAH/373

Summary

Brief summary

Wrist fractures in patients are commonly managed using internal fixation. At the Royal Adelaide Hospital last year, 175 distal radius plating procedures were performed. Austofix have designed a new plate, the “VRP 2.0”, with the following proposed advantages over the current commonly available volar radial plate systems :
1.	The plate is universal and not “sided” – this has beneficial effects in simplifying implant choice in theatre, as well as minimising hospital stock / inventory
2.	The Locking mechanism is unique, and patented
3.	The plate is lower profile than many on the market
4.	The available angle for the variable angle screws has a range of 40 degrees, compared to 30 degrees for other systems. This may allow more accurate fragment specific fixation, and thus improve maintenance of fracture reduction, and hence eventual functional outcome.
5.	The system offers improved instrumentation over currently used systems

To confirm the clinical benefits of the Austofix VRP 2.0 plate system a combined prospective randomised controlled trial is proposed. This trial will compare outcomes of patients managed with the Austofix VRP 2.0 vs those managed with a conventional alternative. The VRP 2.0 plate is TGA registered, and on the approved list of implants with SA Health.

Study Hypothesis:
Adults with closed distal radius fractures who are managed operatively using the VRP 2.0 plate will perform at least 10 points better on the Patient-rated Wrist Evaluation (PRWE) score than those managed operatively using a conventional distal radius locking plate.

Null hypothesis: 
There is no difference in clinical outcome up to one year post injury between patients managed with these 2 different plating systems.

Aim:

This study aims to provide high quality evidence for the effectiveness of surgical treatment of distal radius fractures using 2 different plating systems. It is proposed that the study will be conducted using a randomised controlled trial. Results will support and influence the future treatment of this common injury for optimal patient outcome.

Trial website

None

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

A/Prof Mark Rickman

Address

Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000

Country

Australia

Phone

+61 8 82225535

Fax

mark.rickman@sa.gov.au

Contact person for public queries

Name

Mark Rickman

Address

Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000

Country

Australia

Phone

+61 8 82225535

Fax

mark.rickman@sa.gov.au

Contact person for scientific queries

Name

Mark Rickman

Address

Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000

Country

Australia

Phone

+61 8 82225535

Fax

mark.rickman@sa.gov.au

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

Source	Title	Year of Publication	DOI
Embase	POWIFF- Prospective study of wrist internal fixation of fracture: A protocol for a single centre, superiority, randomised controlled trial to study the efficacy of the VRP (2.0) distal radius plate (Austofix) versus the VA-LCP (Depuy-Synthes) for distal radius fractures.	2018	https://dx.doi.org/10.1186/s12891-018-2052-4

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically