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The Outcomes of Proximal Humerus Fractures in Children

Proximal Humerus Fractures in Children: The Outcomes of Conservative Management

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02863289
Enrollment
118
Registered
2016-08-11
Start date
2016-10-31
Completion date
2017-03-31
Last updated
2019-03-07

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

Conditions

Humeral Fractures

Brief summary

To date, the clinical benefits and harms of surgical intervention in proximal humerus fractures in children remain debatable. The practical question raised by orthopaedic surgeons is: for children and adolescent, are the clinical and radiological outcomes after non-operative management as equivalent as after surgical management for proximal humerus fractures? The investigators' hypothesis is that due to the healing potential of the proximal humerus, the outcome from this fracture is usually excellent. The investigators have applied for Caldicott approval to identify a cohort of eligible patient from NHS Tayside's radiography service. With the community health index (CHI) number, the investigators can review all shoulder X-rays performed in children and adolescents, aged from 10 to 18-year-old in NHS Tayside, from 2008 to 2015. The Caldicott approval also allowed the investigators to obtain clinical communication from the Clinical Portal (electronic summary healthcare records). The investigators will then conduct mail questionnaires, based on the Upper Extremities Functional Index (UEFI). The investigators will send out invitation letter with participation information and the UEFI questionnaires to the eligible patients; with return postages. If no response within 2 weeks, the investigators will send out 1 further reminder. If no further response, the patient will be excluded from the study.

Detailed description

Proximal humerus fractures in children are relatively uncommon and most of them do not require surgical treatment due to the healing potential in children. The management of proximal humerus fractures in children subsequently underwent a major change with the introduction of surgical metal rod nailing. Despite that, the best criteria for choosing between these two treatment options are still not agreed upon. To date, the clinical benefits and harms of surgical intervention in proximal humerus fractures in children remain debatable. The investigators hypothesised that the outcomes of the non-operative management for proximal humerus fractures to remain excellent due to the healing ability of children. If good clinical results are achieved in our patient cohort, the investigators would like to send out the message that non-operative treatment for proximal humerus fractures in children should be recommended, even for those severely displaced fractures. With Caldicott approval, the investigators can review the X-rays performed in children and adolescents, aged from 10 to 18-year-old in NHS Tayside, from 2008 to 2015. By using the Picture Archiving and Communication System (PACS), the investigators will be able to identify the cohort of patients who had proximal humerus fractures from the X-rays. The Caldicott approval also allowed the investigators to obtain clinical communication from Clinical Portal. The identified potential participants will be approached by the paediatric orthopaedic team. An invitation letter, a participant information sheet and questionnaire, based on UEFI will be sent to all potential participants by the care team via post. If no response within 2 weeks, the investigators will send out 1 further reminder. If no further response, the patient will be excluded from the study.

Interventions

None listed

Sponsors

NHS Tayside
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Within age limit * Had proximal humerus fracture within study year * Return questionnaire

Exclusion criteria

* No proximal humerus fractures * Not return mail questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)From year 2008 to 2015Mail questionnaires based on the Upper Extremities Functional Index (UEFI) with return postages were sent out to the eligible cohort. UEFI range between 0 to 59, where the higher the UEFI, the better the functional outcomes.

Secondary

MeasureTime frameDescription
Number of Participants With Indicated Outcomes as Assessed by Radiological ParametersFrom year 2008 to 2015All shoulder X-rays performed in patients aged from 10 to 18-year-old and from 2008 to 2015 were reviewed. Radiological parameters, including degree of displacement and angulation; and any radiological residual deformities were recorded.

Participant flow

Recruitment details

From 01/11/2016 to 01/03/2017 in Tayside.

Pre-assignment details

All children who sustained proximal humerus fracture at age of 10 to 18 years old in Tayside.

Participants by arm

ArmCount
Children With Proximal Humerus Fractures
Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
118
Total118

Baseline characteristics

CharacteristicChildren With Proximal Humerus Fractures
Age, Categorical
<=18 years
118 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous12 years
Region of Enrollment
United Kingdom
118 Participants
Sex: Female, Male
Female
56 Participants
Sex: Female, Male
Male
62 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 118
serious
Total, serious adverse events
0 / 118

Outcome results

Primary

Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)

Mail questionnaires based on the Upper Extremities Functional Index (UEFI) with return postages were sent out to the eligible cohort. UEFI range between 0 to 59, where the higher the UEFI, the better the functional outcomes.

Time frame: From year 2008 to 2015

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Children With Proximal Humerus FracturesNumber of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)Presence of Pain4 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)Any difference between injured and non-injured arm4 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)UEFI of 59 points24 Participants
Secondary

Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters

All shoulder X-rays performed in patients aged from 10 to 18-year-old and from 2008 to 2015 were reviewed. Radiological parameters, including degree of displacement and angulation; and any radiological residual deformities were recorded.

Time frame: From year 2008 to 2015

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Children With Proximal Humerus FracturesNumber of Participants With Indicated Outcomes as Assessed by Radiological ParametersSurgical neck fracture91 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Outcomes as Assessed by Radiological ParametersPresence of displacement56 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Outcomes as Assessed by Radiological ParametersPresence of angulation84 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Outcomes as Assessed by Radiological ParametersResidual angulation at follow up55 Participants
Children With Proximal Humerus FracturesNumber of Participants With Indicated Outcomes as Assessed by Radiological ParametersWorsened angulation25 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026