The Outcomes of Proximal Humerus Fractures in Children

NCT02863289 | Completed Results DMC

• 1 other identifier: 2016PB01
• Study Type: observational
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Humeral Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters

  From year 2008 to 2015

Study Arms (1)

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.

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• No proximal humerus fractures
• Not return mail questionnaire

Sponsors & Collaborators

• NHS Tayside: lead

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Mr Benedict Clift
• Organization: NHS Tayside

ben.clift@nhs.net

01382 660111

Study Officials

• Jun Wei Lim

  NHS Tayside

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr. Ben Clift

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 7, 2019
• Results First Posted: March 7, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share