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Trial registered on ANZCTR


Registration number
ACTRN12611001096943
Ethics application status
Approved
Date submitted
7/10/2011
Date registered
21/10/2011
Date last updated
21/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised study comparing functional outcomes in patients weightbearing at two weeks versus six weeks following surgical fixation of ankle fracture.
Scientific title
A prospective randomised study comparing functional outcomes in patients weightbearing at two weeks versus six weeks following surgical fixation of ankle fracture.
Secondary ID [1] 273158 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fractures 278912 0
Condition category
Condition code
Injuries and Accidents 279088 279088 0 0
Fractures
Musculoskeletal 279089 279089 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients undergoing open reduction internal fixation for a stable ankle fracture will at 2 weeks post surgery have a permanent full below knee cast applied made from a synthetic casting material (Dynacast# Prelude) for 4 weeks and be encouraged to weightbear mobilising using crutches or frame until they are mobilising fully weightbearing.
Intervention code [1] 269572 0
Rehabilitation
Comparator / control treatment
patients undergoing open reduction internal fixation for a stable ankle fracture will at 2 weeks post surgery have a permanent full below knee cast applied made from a synthetic casting material (Dynacast# Prelude) for 4 weeks and be non weightbearing mobilising with crutches or a frame.
Control group
Active

Outcomes
Primary outcome [1] 279729 0
Olerud & Molander Ankle Score measures:
1. ankle symptoms e.g., pain, swelling
2. functional outcomes e.g., gait supports, stair climbing, jumping
Timepoint [1] 279729 0
2 weeks, 6 weeks, 3 months and 6 months post surgery
Secondary outcome [1] 294322 0
EQ-5D (English version for Australia) is a standardised instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status.
Timepoint [1] 294322 0
2 weeks, 6 weeks, 3 months and 6 months post surgery

Eligibility
Key inclusion criteria
Patients with a closed ankle fracture that has a stable syndesmosis and an uninjured posterior syndesmosis that requires open reduction internal fixation .
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an open ankle fracture considered unstable for weightbearing at 2 weeks post surgery, e.g. those with unstable syndesmosis requiring a screw across the syndesmosis and those with an injured posterior syndesmosis.

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 who have undergone open-reduction internal fixation surgery of their ankle fracture who fit the inclusion criteria will be recruited. These patients will undergo screening for any exclusion criteria. They will then be randomly allocated via sealed opaque envelope to either the early weightbearing group or the traditional six weeks immobilization group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A 1:1 block randomisation will be used. The assignments are predetermined through a schedule generated using randomly permuted blocks with random block sizes method. The randomisation plan generator available on the randomisation.com website was used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269973 0
Self funded/Unfunded
Name [1] 269973 0
Country [1] 269973 0
Australia
Funding source category [2] 270066 0
Self funded/Unfunded
Name [2] 270066 0
Country [2] 270066 0
Primary sponsor type
Other
Name
Orthopaedic Unit
Address
Flinders Medical Centre
Flinders Dve
BEDFORD PARK SA 5042
Country
Australia
Secondary sponsor category [1] 268966 0
None
Name [1] 268966 0
Address [1] 268966 0
Country [1] 268966 0
Secondary sponsor category [2] 269029 0
None
Name [2] 269029 0
Address [2] 269029 0
Country [2] 269029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271937 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 271937 0
Ethics committee country [1] 271937 0
Australia
Date submitted for ethics approval [1] 271937 0
01/07/2011
Approval date [1] 271937 0
13/07/2011
Ethics approval number [1] 271937 0
1/11/0318

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33232 0
Address 33232 0
Country 33232 0
Phone 33232 0
Fax 33232 0
Email 33232 0
Contact person for public queries
Name 16479 0
Ms Vanessa Wells
Address 16479 0
Orthopaedic Unit
Flinders Medical Centre
Flinders Dve
BEDFORD PARK SA 5042
Country 16479 0
Australia
Phone 16479 0
+61 8 82044673
Fax 16479 0
Email 16479 0
[email protected]
Contact person for scientific queries
Name 7407 0
Ms Vanessa Wells
Address 7407 0
Orthopaedic Unit
Flinders Medical Centre
Flinders Dve
BEDFORD PARK SA 5042
Country 7407 0
Australia
Phone 7407 0
+61 8 82044673
Fax 7407 0
Email 7407 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
No additional documents have been identified.