The Outcomes of Proximal Humerus Fractures in Children

Humeral Fractures Clinical Trial

Official title:

Proximal Humerus Fractures in Children: The Outcomes of Conservative Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863289
• Other study ID #: 2016PB01
• Status: Completed
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2018
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Within age limit

• Had proximal humerus fracture within study year

• Return questionnaire

Exclusion Criteria:

• No proximal humerus fractures

• Not return mail questionnaire

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NHS Tayside

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From year 2008 to 2015
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.	From year 2008 to 2015