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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.
Scientific title
Outcomes of proximal humerus fractures in children.
Secondary ID [1] 306243 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal humerus fracture 324974 0
Condition category
Condition code
Injuries and Accidents 322408 322408 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
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.
Intervention code [1] 322649 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330172 0
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.
Timepoint [1] 330172 0
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.
Primary outcome [2] 330258 0
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.
Timepoint [2] 330258 0
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.
Primary outcome [3] 330259 0
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.
Timepoint [3] 330259 0
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.
Secondary outcome [1] 405126 0
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.
Timepoint [1] 405126 0
This will be assessed during a brief clinic appointment, one to two weeks following the telephone interview.
Secondary outcome [2] 405127 0
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.
Timepoint [2] 405127 0
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.
Secondary outcome [3] 405128 0
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.
Timepoint [3] 405128 0
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.

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.
Minimum age
2 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21514 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 36421 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 310591 0
University
Name [1] 310591 0
The University of Adelaide
Country [1] 310591 0
Australia
Primary sponsor type
Individual
Name
Dr Samuel Abbot
Address
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
Country
Australia
Secondary sponsor category [1] 311782 0
None
Name [1] 311782 0
Address [1] 311782 0
Country [1] 311782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310195 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 310195 0
Ethics committee country [1] 310195 0
Australia
Date submitted for ethics approval [1] 310195 0
17/10/2021
Approval date [1] 310195 0
19/10/2021
Ethics approval number [1] 310195 0
2021/HRE00250

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116830 0
Dr Samuel Abbot
Address 116830 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
Country 116830 0
Australia
Phone 116830 0
+61 411 362 492
Fax 116830 0
Email 116830 0
Samuel.Abbot@sa.gov.au
Contact person for public queries
Name 116831 0
Samuel Abbot
Address 116831 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
Country 116831 0
Australia
Phone 116831 0
+61 8 8161 7000
Fax 116831 0
Email 116831 0
Samuel.Abbot@sa.gov.au
Contact person for scientific queries
Name 116832 0
Samuel Abbot
Address 116832 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia 5006
Country 116832 0
Australia
Phone 116832 0
+61 8 8161 7000
Fax 116832 0
Email 116832 0
Samuel.Abbot@sa.gov.au

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14715Study protocol    383443-(Uploaded-19-01-2022-13-33-05)-Study-related document.docx
14716Informed consent form    383443-(Uploaded-26-01-2022-20-51-34)-Study-related document.docx
14717Ethical 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
SourceTitleYear of PublicationDOI
EmbaseOutcomes of proximal humerus fractures in children: a study protocol for a retrospective cohort study.2022https://dx.doi.org/10.1136/bmjopen-2022-062586
N.B. These documents automatically identified may not have been verified by the study sponsor.