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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] 290406 0
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 300743 0
Condition category
Condition code
Injuries and Accidents 300575 300575 0 0
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] 296237 0
Treatment: Surgery
Intervention code [2] 296404 0
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] 299995 0
PRWE Score - includes wrist pain and function
Timepoint [1] 299995 0
6 weeks, 3 months, 12 months
Secondary outcome [1] 328768 0
Complications - prospectively recorded at each clinic visit / phone interview.
Timepoint [1] 328768 0
Up to 1 year
Secondary outcome [2] 328770 0
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] 328770 0
3 months
Secondary outcome [3] 328771 0
Fracture reduction acheived at surgery and maintained at 1 year - measured against normal values on plain radiographs
Timepoint [3] 328771 0
immediate post-op, and 1 year
Secondary outcome [4] 328772 0
DASH Scores - disability / symptoms only
Timepoint [4] 328772 0
6 weeks, 3 months, 1 year
Secondary outcome [5] 328773 0
EQ5D - health status score
Timepoint [5] 328773 0
3 months, 1 year
Secondary outcome [6] 328774 0
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] 328774 0
3 months, 1 year
Secondary outcome [7] 328775 0
Time to resumption of work, recorded at clinic visits.
Timepoint [7] 328775 0
6 weeks, 3 months, 1 year
Secondary outcome [8] 329305 0
Operative time - from theatre operation record, time knife to skin to dressing applied.
Timepoint [8] 329305 0
End of surgery
Secondary outcome [9] 329306 0
Number of screws used - from operative records
Timepoint [9] 329306 0
End of surgery
Secondary outcome [10] 329307 0
Flouroscopy time - from operative records
Timepoint [10] 329307 0
End of surgery
Secondary outcome [11] 329309 0
Patient perceived percentage global return of function, recorded at clinic reviews as a simple question
Timepoint [11] 329309 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294830 0
Hospital
Name [1] 294830 0
Royal Adelaide Hospital
Address [1] 294830 0
North Terrace
Adelaide SA5000
Country [1] 294830 0
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] 293672 0
None
Name [1] 293672 0
Address [1] 293672 0
Country [1] 293672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296218 0
HREC Royal Adelaide Hospital
Ethics committee address [1] 296218 0
North Terrace
Adelaide SA5000
Ethics committee country [1] 296218 0
Australia
Date submitted for ethics approval [1] 296218 0
13/09/2016
Approval date [1] 296218 0
27/10/2016
Ethics approval number [1] 296218 0
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 69986 0
A/Prof Mark Rickman
Address 69986 0
Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000
Country 69986 0
Australia
Phone 69986 0
+61 8 82225535
Fax 69986 0
Email 69986 0
mark.rickman@sa.gov.au
Contact person for public queries
Name 69987 0
A/Prof Mark Rickman
Address 69987 0
Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000
Country 69987 0
Australia
Phone 69987 0
+61 8 82225535
Fax 69987 0
Email 69987 0
mark.rickman@sa.gov.au
Contact person for scientific queries
Name 69988 0
A/Prof Mark Rickman
Address 69988 0
Level 4, Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA5000
Country 69988 0
Australia
Phone 69988 0
+61 8 82225535
Fax 69988 0
Email 69988 0
mark.rickman@sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results