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Trial registered on ANZCTR


Registration number
ACTRN12614001050640
Ethics application status
Not yet submitted
Date submitted
16/09/2014
Date registered
2/10/2014
Date last updated
2/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Early mobilization vs delayed mobilisation following the use of a volar locking plate with non-vascularised bone graft in scaphoid non-union. A multicentred randomised controlled-trial.
Scientific title
In patients with scaphoid non-union is early mobilisation or delayed mobilisation post open reduction and internal fixation (ORIF) more effective in achieving union of fracture? A multicentred randomised controlled trial.
Secondary ID [1] 285346 0
Nil
Universal Trial Number (UTN)
U1111-1161-7872
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scaphoid non-union 293070 0
Condition category
Condition code
Musculoskeletal 293345 293345 0 0
Other muscular and skeletal disorders
Injuries and Accidents 293440 293440 0 0
Fractures
Physical Medicine / Rehabilitation 293457 293457 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo an open reduction internal fixation using an anatomically contoured scaphoid specific locking plate with non-vascularised bone graft. The surgery will take approximately 1 hr. The intervention group will be able to mobilise post-operatively. A bulky dressing will be applied (velband and crepe). This will be removed at the 2 week wound review.
Intervention code [1] 290261 0
Rehabilitation
Intervention code [2] 290333 0
Treatment: Surgery
Comparator / control treatment
Control group will be immobilised with a below elbow cast for 6 weeks post operation.
Control group
Active

Outcomes
Primary outcome [1] 293179 0
Scaphoid union. Assessed using CT imaging.
Timepoint [1] 293179 0
3 months post operatively
Secondary outcome [1] 310510 0
Review of contributing factors to non-union. Assessed by performing a logistical regression on co-morbidities and their impact on development of non-union.

Co-morbidities of interest will be recorded on the patients data sheet at time of enrolment in the trial. These will include diabetes, smoking and obesity.
Timepoint [1] 310510 0
Preoperative

Eligibility
Key inclusion criteria
All adult patients (age >18yrs) with established non-union scaphoid fractures will be considered for inclusion.

Non-union will be defined as a persistence of radiological evidence of non-union 3 months from injury date on either x-ray or CT imaging.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had a previous failed open reduction, internal fixation procedure.

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 will be recruited from the fracture clinic as an outpatient. Patients with a non union scaphoid fracture that fulfil inclusion criteria will be approached for consent. Allocation concealment will be through the sealed envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The research design is a standard block randomisation. Random sequence will be generated using the STATA software package.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 2985 0
Western Hospital - Footscray
Recruitment hospital [2] 2986 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 8707 0
3011 - Footscray
Recruitment postcode(s) [2] 8708 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 289958 0
Self funded/Unfunded
Name [1] 289958 0
Address [1] 289958 0
Country [1] 289958 0
Primary sponsor type
Individual
Name
Dr Andrew Fraval
Address
Western Health
Gordon St, Footscray
VIC 3011
Country
Australia
Secondary sponsor category [1] 288649 0
None
Name [1] 288649 0
Address [1] 288649 0
Country [1] 288649 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291675 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 291675 0
The Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050
Ethics committee country [1] 291675 0
Australia
Date submitted for ethics approval [1] 291675 0
27/08/2014
Approval date [1] 291675 0
Ethics approval number [1] 291675 0
HREC/14/MH/247

Summary
Brief summary
This is a randomised controlled trial analysing two rehabilitation techniques for non-union scaphoid fractures. This study aims to investigate whether the use of an anatomically contoured scaphoid specific locking plate with non-vascularised bone graft in scaphoid non-union allows for early mobilisation and union.
This study will be conducted as a randomised controlled trial with the control arm receiving the gold standard rehabilitation (1) and the experimental arm receiving no plaster and early mobilisation.
Our hypothesis is there will be no difference in union rates between the gold standard and experimental cohorts. We are hoping this will result in a change in standard practice for this group of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51470 0
Dr Andrew Fraval
Address 51470 0
Western Health
Gordon St, Footscray
VIC 3011
Country 51470 0
Australia
Phone 51470 0
+61 423 155 386
Fax 51470 0
Email 51470 0
afraval@mac.com
Contact person for public queries
Name 51471 0
Dr Andrew Fraval
Address 51471 0
Western Health
Gordon St, Footscray
VIC 3011
Country 51471 0
Australia
Phone 51471 0
+61 423 155 386
Fax 51471 0
Email 51471 0
afraval@mac.com
Contact person for scientific queries
Name 51472 0
Dr Andrew Fraval
Address 51472 0
Western Health
Gordon St, Footscray
VIC 3011
Country 51472 0
Australia
Phone 51472 0
+61 423 155 386
Fax 51472 0
Email 51472 0
afraval@mac.com

No data has been provided for results reporting
Summary results
Not applicable