Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001319369
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
14/09/2017
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SHAFT – Shaft of Humerus Acute Fixation Trial. A study comparing clinical outcomes of the management of arm fractures in adults using non-operative treatment and operative treatment (plates or nails).
Scientific title
A prospective Randomised Controlled Trial comparing clinical outcomes for humeral shaft fractures in adults treated with and without surgery
Secondary ID [1] 292765 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SHAFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Humerus fracture 304559 0
Condition category
Condition code
Injuries and Accidents 303883 303883 0 0
Fractures
Musculoskeletal 303975 303975 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient will be randomised to intervention 1 or a control treatment to treat their humeral shaft fracture.
Intervention 1 is operative treatment of the humeral shaft fracture. If randomised to this treatment the patient with undergo internal fixation of the humerus fracture by the treating Consultant Orthopaedic Surgeon. They may use whichever fixation method is usual for them. (In practice this will mean a plate and screws or an intramedullary nail fixation method.) The operation will take between 60 and 120 minutes. When well enough following the operation the patient will be allowed home and to begin moving their arm. They will be reviewed in the fracture clinic as is routine for these injuries at 2 weeks, 6 weeks and 12 weeks following their operation for a clinical check and check X-ray by the treating Orthopaedic Surgeon
Intervention code [1] 299002 0
Treatment: Surgery
Comparator / control treatment
The control treatment will be non-operative treatment which will consist of a temporary plaster on the arm until the patient is comfortable enough to be placed into a standard removable humeral brace. (This timescale for the change between plaster and brace will be slightly variable between patients but the aim would be to get all patients treated with the control treatment into a brace by the end of the first week of treatment,)
The length of time in the brace will be determined by the treating Orthopaedic Surgeon and will be judged by pain level and degree of fracture union as determined by normal clinic attendance and routine check X-ray. This period of time in brace may be as long as 3 months. Plasters will be applied by suitably trained doctors or nursers from the Emergency or Orthopaedic departments. The change to a brace will be supervised by a suitably experienced and trained Orthopaedic Doctor or Nurse. Clinic visits and check X-rays at fracture clinic will likely be undertaken at 1 week, 2 weeks, 6 weeks and 12 weeks post injury. If additional clinic visits or X-rays are required for clinical reasons, this will be determined by the treating Orthopaedic Consultant Surgeon.
Control group
Active

Outcomes
Primary outcome [1] 303235 0
DASH (Disability of Shoulder and Hand) scores between groups
Timepoint [1] 303235 0
12 months
Secondary outcome [1] 338310 0
DASH (Disability of Shoulder and hand) scores
Timepoint [1] 338310 0
2, 4, 6, 12 and 26 weeks
Secondary outcome [2] 338311 0
Pain scores - VAS 100mm analogue scale
Timepoint [2] 338311 0
2, 4, 6, 12, 26 and 52 weeks
Secondary outcome [3] 338312 0
Complications such as infection, nerve injury metalwork failure. These will be assessed clinically and radiologically post-operatively and at each clinical follow up (2, 6, 12, 26 and 52 weeks) and documented appropriately
Timepoint [3] 338312 0
2, 6, 12, 26 and 52 weeks
Secondary outcome [4] 338313 0
Re-operation rates. Any further procedure following the initial procedure will be documented and expressed as a re-operation rate compared to the total number of people operated on. Re-operation could happen at any time but will be classified as early (<2 weeks), (intermediate 2-12 weeks), or late (beyond 12 weeks)
Timepoint [4] 338313 0
as per the early, intermediate and late check points - this will be assessed at 2, 12 and 52 weeks
Secondary outcome [5] 338314 0
Fracture non-union rates - this is assessed by radiological evaluation where there requires to be bridging callus on 3 out of 4 cortices for radiological union or the absence of a fracture line in the setting of plate fixation.
Timepoint [5] 338314 0
X-rays taken at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [6] 338315 0
Return to Activities (Driving/Work). This will be assessed by direct questioning at clinic attendance to document the time after injury each patient returned to driving and work
This will be a simple yes no question as to whether the patient has returned to driving and/or work.
Timepoint [6] 338315 0
This will be asked at each clinic follow up (2, 6, 12, 26, 52 weeks)
Secondary outcome [7] 338316 0
Activity levels as monitored by activity bracelets. These will be worn by patients for the first week of each month for the first four months after injury.
Timepoint [7] 338316 0
Weeks 2, 6, 10, 12 post injury/treatment
Secondary outcome [8] 338317 0
Economic Analysis (Cost utility for each treatment arm). This will be calculated using costs of treatment as defined by the available schedules as well as including the patient out of pocket costs over their recovery period (including absence from work). The difference between the treatment groups will be calculated and a QALY figure assigned to each treatment groups
Timepoint [8] 338317 0
1 year
Secondary outcome [9] 338596 0
Readmission rates. The number of patients readmitted to hospital for further treatment related to their fracture will be compared between the two treatment groups. This will be assessed at early, middle and late timepoints (before 2 weeks, between 2 and 12 weeks and beyond 12 weeks post initial management.
Timepoint [9] 338596 0
2 weeks, 12 weeks and 52 weeks

Eligibility
Key inclusion criteria
Closed fracture presenting within 14 days.

Humerus shaft fracture amenable to simple plate or nail fixation (ie not requiring peri-articular plates) and without extension into either metaphysis.

Medically fit enough to undergo surgery.

No active malignancy.

Ability to provide informed consent.

English language sufficient to complete online outcome questionnaires.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Open fractures

Other simultaneous injuries limited to:

Other fractures or joint injuries in the same arm
Any injury requiring restricted use of the contra-lateral upper limb
Any injury requiring restricted weight bearing on either lower limb
Head injuries


Previous fractures with internal fixation in the same bone.

Patients with no access to emails or internet usage.

Patients with poor command of English language.

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)
Concealed - Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated - stratified by gender, handedness and hospital site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
difference of 10 points on the DASH (out of 100) has been shown as the minimum clinically important difference necessary to detect improvement. The standard deviation of the DASH score is approximately 20, therefore using a significance level of 0.05 and power of 90%, 85 patients are required in each group. Allowing for 15% loss to follow up, we aim to recruit a total of 100 patients per group.
Continuous data such as the DASH and pain scores will be analysed using a Mann-Whitney U test to compare the two independent groups. Categorical outcomes (eg union, re-operation or re-admission rates) will be analysed using a chi-squared test. The statistician performing the analysis will be blinded to the treatment groups.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2019
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 8923 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 8924 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 8925 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 8926 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 8927 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 8928 0
The Canberra Hospital - Garran
Recruitment hospital [7] 8929 0
John Hunter Hospital - New Lambton
Recruitment hospital [8] 8930 0
St George Hospital - Kogarah
Recruitment hospital [9] 8931 0
The Sutherland Hospital - Caringbah
Recruitment hospital [10] 8932 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 8933 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [12] 8934 0
Westmead Hospital - Westmead
Recruitment hospital [13] 8935 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [14] 8936 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 17304 0
2050 - Camperdown
Recruitment postcode(s) [2] 17305 0
2145 - Westmead
Recruitment postcode(s) [3] 17298 0
2170 - Liverpool
Recruitment postcode(s) [4] 17301 0
2217 - Kogarah
Recruitment postcode(s) [5] 17302 0
2229 - Caringbah
Recruitment postcode(s) [6] 17300 0
2305 - New Lambton
Recruitment postcode(s) [7] 17299 0
2605 - Garran
Recruitment postcode(s) [8] 17306 0
3050 - Parkville
Recruitment postcode(s) [9] 17307 0
4029 - Herston
Recruitment postcode(s) [10] 17303 0
4575 - Birtinya
Recruitment postcode(s) [11] 17294 0
5000 - Adelaide
Recruitment postcode(s) [12] 17295 0
5011 - Woodville
Recruitment postcode(s) [13] 17297 0
5042 - Bedford Park
Recruitment postcode(s) [14] 17296 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 297399 0
Commercial sector/Industry
Name [1] 297399 0
Johnson & Johnson Medical Pty Ltd
Country [1] 297399 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network Incorporated
Address
Level 3 Margaret Graham Building, Royal Adelaide Hospital , North Terrace, Adelaide SA 5000.
Country
Australia
Secondary sponsor category [1] 296388 0
Individual
Name [1] 296388 0
A/Prof Mark Rickman
Address [1] 296388 0
Discipline of Trauma & Orthopaedics, Level 4 Bice Building, Royal Adelaide Hospital
North Terrace, Adelaide SA 5000.
Country [1] 296388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298503 0
Royal Adelaide Human Research Ethics Committee
Ethics committee address [1] 298503 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000
Ethics committee country [1] 298503 0
Australia
Date submitted for ethics approval [1] 298503 0
20/07/2017
Approval date [1] 298503 0
08/08/2017
Ethics approval number [1] 298503 0
HREC/17/RAH/253

Summary
Brief summary
A multicentre randomised controlled trial comparing outcomes for humeral shaft fractures (arm fractures) treated with and without an operation to 'fix' the bone (with a metal plate and screws or a rod versus treating with an arm brace).
200 patients will be randomised over 14 hospitals (100 to each treatment type) and followed up over one year to determine if there is any difference in outcome.

The hypothesis is that those treated with surgery will have better outcomes. The primary outcomes is the difference between the groups for scores on the Disabilities of hand and shoulder survey at one year post injury.
Other outcome measure will be fracture healing, pain and quality of life scores, complication rates and return to activity levels as well as a cost analysis of both treatment types.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77286 0
A/Prof Mark Rickman
Address 77286 0
Department of Trauma and Orthopaedics
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000
Country 77286 0
Australia
Phone 77286 0
+61427722738
Fax 77286 0
Email 77286 0
mark.rickman@sa.gov.au
Contact person for public queries
Name 77287 0
Mr Christopher Munro
Address 77287 0
Department of Trauma and Orthopaedics
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000
Country 77287 0
Australia
Phone 77287 0
+61427909195
Fax 77287 0
Email 77287 0
christopher.munro@sa.gov.au
Contact person for scientific queries
Name 77288 0
Mr Christopher Munro
Address 77288 0
Department of Trauma and Orthopaedics
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000
Country 77288 0
Australia
Phone 77288 0
+61427909195
Fax 77288 0
Email 77288 0
christopher.munro@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.