Trial Outcomes & Findings for The Outcomes of Proximal Humerus Fractures in Children (NCT NCT02863289)
NCT ID: NCT02863289
Last Updated: 2019-03-07
Results Overview
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.
COMPLETED
118 participants
From year 2008 to 2015
2019-03-07
Participant Flow
From 01/11/2016 to 01/03/2017 in Tayside.
All children who sustained proximal humerus fracture at age of 10 to 18 years old in Tayside.
Participant milestones
| Measure |
Children With Proximal Humerus Fractures
Children aged from 10 to 18-year-old in NHS Tayside who sustained proximal humerus fractures during year 2008 to 2015.
|
|---|---|
|
Overall Study
STARTED
|
118
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
83
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Outcomes of Proximal Humerus Fractures in Children
Baseline characteristics by cohort
| Measure |
Children With Proximal Humerus Fractures
n=118 Participants
Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
|
|---|---|
|
Age, Categorical
<=18 years
|
118 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Children With Proximal Humerus Fractures
n=35 Participants
Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
|
|---|---|
|
Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)
Presence of Pain
|
4 Participants
|
|
Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)
Any difference between injured and non-injured arm
|
4 Participants
|
|
Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)
UEFI of 59 points
|
24 Participants
|
SECONDARY outcome
Timeframe: From 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.
Outcome measures
| Measure |
Children With Proximal Humerus Fractures
n=118 Participants
Children aged from 10 to 18-year-old in NHS Tayside whom sustained proximal humerus fractures during year 2008 to 2015.
|
|---|---|
|
Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
Surgical neck fracture
|
91 Participants
|
|
Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
Presence of displacement
|
56 Participants
|
|
Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
Presence of angulation
|
84 Participants
|
|
Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
Residual angulation at follow up
|
55 Participants
|
|
Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters
Worsened angulation
|
25 Participants
|
Adverse Events
Children With Proximal Humerus Fractures
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place