Clinical trial NCT02863289: The Outcomes of Proximal Humerus Fractures in Children
Official title: Proximal Humerus Fractures in Children: The Outcomes of Conservative Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humeral Fractures
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 118
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 10 to 18-year-old in NHS Tayside who had proximal humerus fractures during year 2008 to 2015.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No proximal humerus fractures
* Not return mail questionnaire

Primary outcomes:
measure: Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)
timeFrame: From year 2008 to 2015
Secondary outcomes:
measure: Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
timeFrame: From year 2008 to 2015
Other outcomes:
Locations:
Study officials:
affiliation: NHS Tayside
name: Jun Wei Lim
role: PRINCIPAL_INVESTIGATOR
References: