N/A
N=118
The Outcomes of Proximal Humerus Fractures in Children
Humeral Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02863289 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI) — 4; 4; 24 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- NHS Tayside
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI) |
4; 4; 24 | — |
| SECONDARY Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters |
91; 56; 84; 55; 25 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02863289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.