Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000557033
Ethics application status
Not yet submitted
Date submitted
7/07/2010
Date registered
9/07/2010
Date last updated
9/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Early mobilisation post ankle fracture fixation
Scientific title
The effect of mobilisation versus cast on return to work and ankle function following ankle fracture fixation
Secondary ID [1] 252167 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 257710 0
Condition category
Condition code
Injuries and Accidents 257879 257879 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in intervention group will have no cast post fixation of their ankle fracture. They will go in a moonboot for comfort only, and will be shown range of motion ankle joint exercises by physiotherapist on the ward prior to discharge. They will still be non weight bearing for six weeks. No formal outpateint physiotherapy sessions will take place in the first six weeks. The frequency of exercises will not be specified as the importance here is placed on allowing the patient freedom to move their ankle at their will post surgery.
Intervention code [1] 256764 0
Rehabilitation
Intervention code [2] 256773 0
Treatment: Other
Comparator / control treatment
Cast treatment for six weeks post ankle fracture fixation with non weight bearing restriction on operated limb. After six weeks, the patients in both groups will be allowed to weight bear as tolerated, and will be encouraged to work on range of motion of their ankle joint by the clinician in our clinic. If patients desire, they will be referred to physiotherapist as per our current practice.
Control group
Active

Outcomes
Primary outcome [1] 258744 0
Return to work. This will be assessed via query to ACC (Accident Compensation and Claim) organisation with regards to the date the patients return to 'light duty', 'medium duty', 'heavy duty', and 'full time' work. We believe this is the most accurate method as patient's own account may be unreliable at times.
Timepoint [1] 258744 0
The query to ACC will be made at six months following ankle fracture fixation, as by this stage we expect all our patients to return to work.
Secondary outcome [1] 264794 0
Ankle function score (based on questionnaire and examination in outpatient clinic)
Timepoint [1] 264794 0
At twelve weeks post ankle fracture fixation
Secondary outcome [2] 264806 0
Complications of surgery including infection and failure of fixation
Timepoint [2] 264806 0
At two weeks post fixation - wound check will reveal any infection (defined as wound infection requiring intravenous antibiotics and admission for our study purposes)
At six weeks post fixation - the xrays will reveal failure of fixation.
Any readmission to our hospital in first six weeks will be noted in six weeks clinic visit.

Eligibility
Key inclusion criteria
Ankle fracture (all types) requiring surgical fixation
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with diabetes as a medical comorbidity
Multitrauma (more than one injury in a single event)

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)
Patients with ankle fractures requiring surgery at Whangarei Hospital, New Zealand will be enrolled if they consent. Typically we wait for 7 days before swelling is acceptable for internal fixation and patients can use this time to make their decision.

Allocation concealment method for this study is sealed opaque envelopes. This will be opened by the operating surgeon at commencement of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved by using randomisation table created by a computer software. Envelopes with either "no cast" or "cast" will be opened during surgery. These envelopes will be in a box in acute theatre.

There will be no stratification.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 2748 0
New Zealand
State/province [1] 2748 0

Funding & Sponsors
Funding source category [1] 257260 0
Self funded/Unfunded
Name [1] 257260 0
Country [1] 257260 0
Primary sponsor type
Hospital
Name
Whangarei Hospital
Address
Maunu Road
Whangarei 0110
Country
New Zealand
Secondary sponsor category [1] 256503 0
None
Name [1] 256503 0
Address [1] 256503 0
Country [1] 256503 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259284 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259284 0
3rd Floor, Unisys Building,
650 Great South Road, Penrose
Private Bag 92-522, Wellesley Street
Auckland
Ethics committee country [1] 259284 0
New Zealand
Date submitted for ethics approval [1] 259284 0
09/07/2010
Approval date [1] 259284 0
Ethics approval number [1] 259284 0

Summary
Brief summary
Ankle fractures are common and frequently require fixation. The current practice in Whangarei Hospital and most centres around New Zealand is to immobilise ankles post fixation in a cast for six weeks in order to protect the ankle from wound breakdown and to allow fracture to heal. However, there have been studies over the years that confirm early mobilisation post ankle fixation results in early return to work and no significant complications. A recent literature review confirmed that only one study out of nine showed a higher rate of infection in early mobilisation group.
Our aim is to confirm the positive findings of the literature for our local population. If early mobilisation group in our study return to work sooner and have no further complications compared to cast group, this will change our practice at Whangarei Hospital and potentially at other centres around New Zealand.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 31370 0
Address 31370 0
Country 31370 0
Phone 31370 0
Fax 31370 0
Email 31370 0
Contact person for public queries
Name 14617 0
Ritwik Kejriwal
Address 14617 0
66 Ngahere Drive
Whangarei 0110
Country 14617 0
New Zealand
Phone 14617 0
+64 21620586
Fax 14617 0
Email 14617 0
[email protected]
Contact person for scientific queries
Name 5545 0
Ritwik Kejriwal
Address 5545 0
66 Ngahere Drive
Whangarei 0110
Country 5545 0
New Zealand
Phone 5545 0
+64 21620586
Fax 5545 0
Email 5545 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.