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Outcomes of proximal humerus fractures in children.

Outcomes of proximal humerus fractures in children.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000176763
Enrollment
800
Registered
2022-02-02
Start date
2022-03-01
Completion date
2023-03-01
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 proxim

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.

Sponsors

Dr Samuel Abbot
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
2 Years to 29 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026