Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000160538
Ethics application status
Not yet submitted
Date submitted
1/05/2006
Date registered
5/05/2006
Date last updated
5/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Aggressive mobilisation following fragment specific fixation of distal radius fractures
Scientific title
Aggressive mobilisation following fragment specific fixation of distal radius fractures improves functional outcome of the wrist joint
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radial fractures 1133 0
Condition category
Condition code
Injuries and Accidents 1212 1212 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aggressive physiotherapy is the intervention group. From day 1 post operatively they will receive intense encouragement both active and passive to achieve increased range of motion and grip strength. Both will attend 1-3 sessions per week with encouragement to do home exercises. Treatment will be for 6 months
Intervention code [1] 1010 0
Rehabilitation
Comparator / control treatment
Regular physiotherapy is the control group. They will receive a more moderate form of the aggressive regime.
Control group
Active

Outcomes
Primary outcome [1] 1643 0
Function of the wrist joint. We will use specific wrist scores "The Functional Index" (FI) and "Patient Rated Wrist Evaluation" (PRWE).
Timepoint [1] 1643 0
Tested at 6 weeks, 3 months, and 6 months.
Secondary outcome [1] 2939 0
Loss of fracture position tested
Timepoint [1] 2939 0
At 6 weeks
Secondary outcome [2] 2940 0
Range of motion and grip strength tested
Timepoint [2] 2940 0
At 6 weeks, 3 months and 6 months

Eligibility
Key inclusion criteria
Must be english speaking, of sound mind, to consent. fracture pattern must be complex, requiring at least 2 incisions and at least 2 forms of internal fixation (according to the staff orthoapedic surgeon).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non -english speaking, not of sound mind to consent, fracture not severe enough to require two forms of internal fixation.

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)
Computer generated/Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1324 0
Hospital
Name [1] 1324 0
The Northern Hospital, Melbourne
Country [1] 1324 0
Australia
Primary sponsor type
Individual
Name
Daniel Goldbloom
Address
Country
Secondary sponsor category [1] 1169 0
None
Name [1] 1169 0
Nil
Address [1] 1169 0
Country [1] 1169 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
To investigate whether aggressive physiotherapy achieves a better functional outcome than regular physiotherapy after operations for wrist fractures. The subjects are blinded. The Physiotherapist is not blinded. The surgeon is also blinded however this fact is not as much of a cornerstone to the study as the blinding status of the patients and the physiotherapist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35456 0
Address 35456 0
Country 35456 0
Phone 35456 0
Fax 35456 0
Email 35456 0
Contact person for public queries
Name 10199 0
Dr Daniel Goldbloom
Address 10199 0
Northern Hospital
185 Cooper St
Epping 3076 VIC
Country 10199 0
Australia
Phone 10199 0
+61 3 84058000
Fax 10199 0
+61 3 84058032
Email 10199 0
[email protected]
Contact person for scientific queries
Name 1127 0
Dr Shane Blackmore
Address 1127 0
Northern Hospital
185 Cooper St
Epping 3076 VIC
Country 1127 0
Australia
Phone 1127 0
+61 3 84058000
Fax 1127 0
+61 3 84058032
Email 1127 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
SourceTitleYear of PublicationDOI
EmbaseRehabilitation for distal radial fractures in adults.2015https://dx.doi.org/10.1002/14651858.CD003324.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.