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Trial registered on ANZCTR
Registration number
ACTRN12622000176763
Ethics application status
Approved
Date submitted
19/01/2022
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Outcomes of proximal humerus fractures in children.
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Scientific title
Outcomes of proximal humerus fractures in children.
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Secondary ID [1]
306243
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N/A
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Proximal humerus fracture
324974
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Condition category
Condition code
Injuries and Accidents
322408
322408
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0
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Fractures
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
1
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Target follow-up type
Years
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Description of intervention(s) / exposure
The exposure is a fracture of the proximal humerus sustained when under the age of 18 years. The principal investigator will identify potential participants from the medical records and radiology database of the Women’s and Children’s Hospital (WCH) in South Australia, which is the tertiary referral paediatric centre for orthopaedics for the state of South Australia and surrounding regions of south-western New South Wales and western Victoria. The diagnosis of each potential participant's proximal humerus fracture will be confirmed upon examination of the plain-film radiographs. We will be observing the functional and quality-of-life outcomes of patients who were diagnosed with a proximal humerus fracture at the WCH between 1st January 2010 and 1st June 2020, when under the age of 18 years.
Once participants have been identified, the status of the patient will be reviewed on the hospital records to ensure that families of the deceased are not contacted. The potential participant will be mailed a copy of the Letter of Invitation to Participants, the Participant Information Sheet and the Informed Consent Form. If they do not opt out of the study, they will then be contacted via telephone two weeks later and given verbal information about the research project. During this telephone call, the principal investigator will go through a structured questionnaire over the phone. The structured questionnaire will involve questions from the QuickDASH, Shoulder Pain and Disability Index (SPADI) and Paediatric Outcomes Data Collection Instrument (PODCI) questionnaires, which are established outcome measures for assessing functional and quality-of-life outcomes following upper limb pathology. Additionally, participants will complete a questionnaire that we have created that asks demographic questions related to the participant’s current occupation, highest level of education, co-morbidities and other musculoskeletal injuries that they have sustained. The telephone interview is not expected to take more than 45 minutes to complete. At the conclusion of the telephone interview, a time and date will be arranged for the participant to have a 15-minute clinic appointment either in-person or via Zoom, to allow for the brief shoulder examination. The clinic appointment will occur 1-2 weeks following the telephone interview for each participant. Both the telephone interview and clinic appointment will be conducted by the principal investigator, who is an orthopaedic registrar with a particular interest in paediatric orthopaedics.
Radiological outcomes following fracture and complications of treatment will also be assessed for each participant up to a maximum of two years post-fracture, by retrospectively accessing imaging results in the hospital's radiology database and the hospital medical records. This will not require any additional involvement by the participant.
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Intervention code [1]
322649
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Diagnosis / Prognosis
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome will be each participant’s pain and quality-of-life outcome, determined by use of the QuickDASH, Shoulder Pain and Disability Index and Paediatric Outcomes Data Collection Instrument, as assessed during a structured questionnaire.
The original Disabilities of the Arm, Shoulder and Hand (DASH) score takes into account daily activities, symptoms and social function, and has been shown to have strong reliability and validity for assessing patients with proximal humerus fractures. From the original 30-item DASH questionnaire, the shorter 11-item QuickDASH was developed, which allows for a reduced time of responding and a lesser administrative burden. The items in the QuickDASH were selected from the original instrument on the basis of them having the highest reliability, validity and responsiveness within each domain of the DASH.
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Assessment method [1]
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Timepoint [1]
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At baseline, when participant undergoes their telephone interview. The time post-fracture will be vary between participants, as we are attempting to ascertain all patients who were diagnosed with a paediatric proximal humerus fracture at the WCH between 1st January 2010 and 1st June 2020.
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Primary outcome [2]
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The SPADI questionnaire was created in 1991 by Roach et al. and consists of two components – one that assesses the participant’s pain levels, and one that assesses the participant’s ability to carry out various functional activities.
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Assessment method [2]
330258
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Timepoint [2]
330258
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At baseline, when participant undergoes their telephone interview. The time post-fracture will be vary between participants, as we are attempting to ascertain all patients who were diagnosed with a paediatric proximal humerus fracture at the WCH between 1st January 2010 and 1st June 2020.
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Primary outcome [3]
330259
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The PODCI is a well-validated musculoskeletal health questionnaire that addresses the child’s mobility, upper limb function, sports and physical function, pain and happiness.
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Assessment method [3]
330259
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Timepoint [3]
330259
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At baseline, when participant undergoes their telephone interview. The time post-fracture will be vary between participants, as we are attempting to ascertain all patients who were diagnosed with a paediatric proximal humerus fracture at the WCH between 1st January 2010 and 1st June 2020.
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Secondary outcome [1]
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Shoulder range of motioned strength. The range-of-motion examination will involve 3 tests, namely the hand-to-neck, hand-to-scapula and hand-to-opposite-scapula tests. Together, these tests assess movement of the shoulder joint in all dimensions, and have been found to have strong intratester and intertester reliability. Participants who are examined in-person will also undergo an assessment of their shoulder’s strength. Their shoulder’s strength in forward-elevation, extension, abduction, adduction, internal rotation and external rotation will be scored out of 5, as according to the classification tool of the American Spinal Injury Association.
Participants who complete an in-person clinical appointment will also undergo an assessment of their shoulder’s strength. Their shoulder’s strength in forward-elevation, extension, abduction, adduction, internal rotation and external rotation will be scored out of 5, as according to the classification tool of the American Spinal Injury Association.
The range-of-motion examination will involve 3 tests, namely the hand-to-neck, hand-to-scapula and hand-to-opposite-scapula tests. Together, these tests assess movement of the shoulder joint in all dimensions, and they have been found to have strong intratester and intertester reliability.
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Assessment method [1]
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Timepoint [1]
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This will be assessed during a brief clinic appointment, one to two weeks following the telephone interview.
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Secondary outcome [2]
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Radiological outcome (including union, malunion, non-union, degree of angulation and/or displacement at final follow-up). To obtain this information, each participant’s follow-up X-rays will be retrospectively reviewed by accessing imaging results in the radiology database of the WCH, with no additional input required by the participant.
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Assessment method [2]
405127
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Timepoint [2]
405127
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This information will be assessed by retrospectively accessing imaging results obtained at the time of final follow-up to a maximum of 2 years post-fracture.
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Secondary outcome [3]
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Complications of treatment. This information will be obtained from both the 45-minute telephone interview and by retrospectively accessing the participants' medical records at the WCH.
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Assessment method [3]
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Timepoint [3]
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This information will be obtained during the telephone interview, and from the medical records of the WCH following the interview. Each participant's interview will occur at the time of enrolment, and their medical records will be assessed up to a maximum of 2 years post-fracture.
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Eligibility
Key inclusion criteria
1. Participants aged under 18 years at the time that they sustained a proximal humerus fracture.
2. All clinical subtypes of proximal humerus fracture, as outlined by the Neer-Horowitz and AO classifications.
3. Participants must have been diagnosed with their proximal humerus fracture at the WCH between 1st January 2010 and 1st June 2020, and had their definitive treatment either there, or at the private practice of WCH-co-employed orthopaedic surgeons.
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Minimum age
2
Years
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Maximum age
29
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients whose fracture was the result of reported or suspected domestic violence, or required mandatory reporting.
2. Patients less than 2 years of age
3. Patients who are unwilling to give consent.
4. Patients who the researcher believes would be unable to participate in the study (e.g. patients who are too young to provide answers in the structured questionnaire).
5. Patients with pathological fractures of the proximal humerus.
6. Patients who are under the Guardianship of the Minister.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
Sample Size Calculation
Our sample size estimation, justification and power calculations were made by a statistician at The University of Adelaide, on the basis of the studies by Canavese et al. and Khan et al., which suggest that between 26% and 37% of paediatric patients with a proximal humerus fracture (PHF) will experience a poorer outcome, defined as a QuickDASH score of 2 or more out of a possible 11 points.
Seven items will be investigated as potential risk factors for a poorer clinical outcome. These items are: age at fracture, age at time of study, gender, ethnicity, fracture severity, co-morbidities, and treatment methodology. The data analysis will be conducted using a multivariable logistic regression, which requires a minimum of 10 events per variable to ensure adequate power and model stability. To allow for more complex relationships (e.g. interactions or non-linear functions) in the data, this will be increased to 15 events per variable. The risk factors of interest translate into 16 predictors. As per the findings of previous studies, it is reasonable to expect that 30% of patients will have a QuickDASH score of at least 2. If 16 predictors are used, this equates to a required sample size of 800 participants..
Data Analysis
Once the relevant demographic, clinical and radiological data have been obtained from each participant, multivariable logistic regression will be performed to determine the clinical variables that are associated with a poorer clinical outcome. As it is hypothesised that patients who were older at the time they sustained their fracture would have had a poorer outcome, as well as patients who sustained a more severely displaced fracture, subgroup analyses will also be performed on:
(i) Participants aged 16 – 18 years old at the time they sustained the PHF
(ii) Participants who sustained Neer-Horowitz grade-III or -IV fractures
(iii) Participants who were skeletally mature at the time of diagnosis.
These subgroup analyses will allow us to assess the efficacy of treating adolescent patients conservatively rather than operatively, depending on the severity of their PHF.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2022
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Actual
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Date of last participant enrolment
Anticipated
1/03/2023
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Actual
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Date of last data collection
Anticipated
1/05/2023
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Actual
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Sample size
Target
800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
21514
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Womens and Childrens Hospital - North Adelaide
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Recruitment postcode(s) [1]
36421
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5006 - North Adelaide
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Funding & Sponsors
Funding source category [1]
310591
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University
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Name [1]
310591
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The University of Adelaide
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Address [1]
310591
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4 North Terrace, Adelaide, South Australia, Australia 5000
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Country [1]
310591
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Australia
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Primary sponsor type
Individual
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Name
Dr Samuel Abbot
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Address
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
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Country
Australia
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Secondary sponsor category [1]
311782
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None
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Name [1]
311782
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Address [1]
311782
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Country [1]
311782
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310195
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Women's and Children's Health Network Human Research Ethics Committee
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Ethics committee address [1]
310195
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Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
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Ethics committee country [1]
310195
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Australia
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Date submitted for ethics approval [1]
310195
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17/10/2021
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Approval date [1]
310195
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19/10/2021
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Ethics approval number [1]
310195
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2021/HRE00250
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Summary
Brief summary
Proximal humerus fractures (fractures of the upper arm) comprise approximately 2% of all fractures in children. While recent studies in adults have demonstrated no benefit of surgery for certain proximal humerus fractures, there remains a paucity of evidence to guide the management of proximal humerus fractures in children, and there is considerable debate in the literature regarding the indications for the different management options. The aim of this project is to analyse the functional and quality-of-life outcomes for a cohort of paediatric patients with proximal humerus fractures, in attempt to inform the management of the various types of proximal humerus fracture in children. A secondary aim is to determine the clinical factors that predict a poorer clinical outcome for paediatric proximal humerus fractures, including patient demographics, fracture pattern and treatment methodology. The hypothesis is that adolescent patients treated non-operatively have a higher risk of a poor clinical outcome, especially when the initial displacement of their fracture is greater.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Samuel Abbot
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Address
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Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
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Country
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Australia
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Phone
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+61 411 362 492
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Fax
116830
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Email
116830
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[email protected]
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Contact person for public queries
Name
116831
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Dr Samuel Abbot
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Address
116831
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Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
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Country
116831
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Australia
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Phone
116831
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+61 8 8161 7000
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Fax
116831
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Email
116831
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[email protected]
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Contact person for scientific queries
Name
116832
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Dr Samuel Abbot
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Address
116832
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Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
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Country
116832
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Australia
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Phone
116832
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+61 8 8161 7000
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Fax
116832
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Email
116832
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14715
Study protocol
383443-(Uploaded-19-01-2022-13-33-05)-Study-related document.docx
14716
Informed consent form
383443-(Uploaded-26-01-2022-20-51-34)-Study-related document.docx
14717
Ethical approval
383443-(Uploaded-19-01-2022-13-36-15)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Outcomes of proximal humerus fractures in children: a study protocol for a retrospective cohort study.
2022
https://dx.doi.org/10.1136/bmjopen-2022-062586
N.B. These documents automatically identified may not have been verified by the study sponsor.
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