Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000948099
Ethics application status
Approved
Date submitted
1/11/2010
Date registered
5/11/2010
Date last updated
23/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Displaced Midshaft Clavicle Fractures: Conservative Management vs Plate Fixation. A Multi-Centre Randomised Controlled Trial
Scientific title
Comparison of DASH scores at 1 year post injury in patients aged 16-60yrs with a displaced fracture of the midshaft of the clavicle treated by non-operative care compared with those treated with plate fixation of the clavicle
Secondary ID [1] 252650 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The optimal management of displaced midshaft clavicle fractures 252063 0
Condition category
Condition code
Injuries and Accidents 252264 252264 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical management of the fracture involving open reduction and internal fixation using a plate.
The operation will be performed at the earliest available time after the patient has been randomised. On average the operation will take between 60 and 90 minutes to perform. The operation will only be performed once on each patient unless there are complications requiring further surgery.
Post operatively the patients will be seen by a physiotherapist and given a guided 16 week physiotherapy program, exactly the same as that given to the control candidates. They will commence this on the day following their operation
Intervention code [1] 241457 0
Treatment: Surgery
Comparator / control treatment
Conservative management: sling and physiotherapy guided rehabilitation program.
This is a 16 week program consisting of progressive range of motion exercises in the initial four weeks, then introducing strengthening exercises from week five onwards.
The patient will be seen by a trained physiotherapist who will give the patient a sheet of exercises and will supervise the patient for a 30 minute session to practice them. The patient will be instructed to perform the exercises daily at home. They will be seen every 1-2 weeks by the physiotherapist for a 30 minute session to ensure that they are managing the exercises and to be supplied with new ones as they advance through the program
This program is the same as the one given to the patients in the Intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 253135 0
Disability of the Arm Shoulder and Hand (DASH) functional scores
This is a short questionnaire completed by the patient that asks questions about the functional status of the patients upper limb.
Timepoint [1] 253135 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [1] 262013 0
Constant Shoulder outcome score
This is an assessment completed by the surgeon at the time of their follow up visits that scores objective measures of shoulder function, primarily strength and range of motion
Timepoint [1] 262013 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [2] 262014 0
Radiographic fracture union
Defined as the presence of bridging trabeculae accross the fracture site on plain X rays. The x rays are taken at follow up visits until union has been demonstrated. They are reviewed by the treating surgical team.
Timepoint [2] 262014 0
6 weeks, 3 months, 6 months, 12 months
Secondary outcome [3] 262015 0
Complications of treatment
These are identified at the standardised follow up visits by asking the patient and reviewing the notes. The Follow Up data collection form specifically asks abou the presence or absence of a list of defined complications: wound problems requiring treatment, non union, symptomatic malunion and complex regional pain syndrome.
Timepoint [3] 262015 0
Recorded at 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [4] 262016 0
Return to work
At each follow up visit the patient is asked for the date that they returned to work. Once this date has been recorded it does not need to be re-recorded on subsequent visits.
Timepoint [4] 262016 0
Date of return to work recorded at 6 weeks, 3 months, 6 months and 12 months

Eligibility
Key inclusion criteria
ALL of following
1. Completely displaced midshaft clavicle fracture
2. Fracture amenable to plate fixation (3 screws either side of fracture)
3.No medical contraindications to general anaesthesia
4.Able to provide informed consent
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ANY of the following
1. Age <16 or >60yrs
2. Fracture of proximal or distal 1/3 of clavicle
3. Pathological fracture
4. Open fracture
5. Fracture seen >28 days after injury
6. Associated neurovascular injury
7. Associated head injury (= GCS<12)
8. Upper extremity fracture distal to the shoulder
9. Inability to comply with follow up
10. Medical contraindication to general anaesthesia
11. Inability to provide consent

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)
Eligible patients enrolled at presentation to the acute Orthopaedic services of the participating centres. Treatment group will be allocated by centrally based randomisation, using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation stratified by centre
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
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
138
Accrual to date
Final
0
Recruitment outside Australia
Country [1] 2297 0
New Zealand
State/province [1] 2297 0
Wellington

Funding & Sponsors
Funding source category [1] 257614 0
Charities/Societies/Foundations
Name [1] 257614 0
Wishbone Trust
Country [1] 257614 0
New Zealand
Primary sponsor type
Hospital
Name
Wellington Hospital Orthopaedic Unit
Address
Wellington Hospital
Capital & Coast District Health Board
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 256836 0
None
Name [1] 256836 0
N/A
Address [1] 256836 0
N/A
Country [1] 256836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244039 0
New Zealand Multi Region Ethics Committee
Ethics committee address [1] 244039 0
Ethics committee country [1] 244039 0
New Zealand
Date submitted for ethics approval [1] 244039 0
01/12/2010
Approval date [1] 244039 0
19/04/2011
Ethics approval number [1] 244039 0
MEC 10/12/120

Summary
Brief summary
The primary purpose of the study is to identify whether the clinical outcomes of mid-shaft clavicle fractures treated with an operation involving fixation with a plate and then physiotherapy are superior to those treated with physiotherapy alone.
The study hypothesis is that there will be no difference in outcomes between the two groups at one year after their injury and subsequent treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30420 0
Dr Harry Clitherow
Address 30420 0
c/o Hutt Valley District Health Board Hutt Hospital, High Street, Lower Hutt Private Bag 31-907 Lower Hutt 5010
Country 30420 0
New Zealand
Phone 30420 0
+64 4 566 6999
Fax 30420 0
Email 30420 0
harry_sc@hotmail.com
Contact person for public queries
Name 13667 0
Dr Dr Harry Stracey-Clitherow
Address 13667 0
c/o Hutt Valley District Health Board
Hutt Hospital, High Street, Lower Hutt
Private Bag 31-907
Lower Hutt
5010
Country 13667 0
New Zealand
Phone 13667 0
+64 4 566 6999
Fax 13667 0
Email 13667 0
midshaftclavicle@gmail.com
Contact person for scientific queries
Name 4595 0
Dr Dr Harry Stracey-Clitherow
Address 4595 0
c/o Hutt Valley District Health Board
Hutt Hospital, High Street, Lower Hutt
Private Bag 31-907
Lower Hutt
5010
Country 4595 0
New Zealand
Phone 4595 0
+64 4 566 6999
Fax 4595 0
Email 4595 0
midshaftclavicle@gmail.com

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

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