An observational study in Humeral Fractures, sponsored by NHS Tayside. Completed. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by NHS Tayside · Observational
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 118 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →NHS Tayside is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged from 10 to 18-year-old in NHS Tayside who had proximal humerus fractures during year 2008 to 2015.
Exclusion Criteria:
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)
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.
Time frame: From year 2008 to 2015
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.
Time frame: From year 2008 to 2015
From 01/11/2016 to 01/03/2017 in Tayside.
| Milestone | Children With Proximal Humerus Fractures |
|---|---|
| Started | 118 |
| Completed | 35 |
| Not completed | 83 |
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.
| Participants | Children With Proximal Humerus Fractures |
|---|---|
| Presence of Pain | 4 |
| Any difference between injured and non-injured arm | 4 |
| UEFI of 59 points | 24 |
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.
| Participants | Radiological Outcomes |
|---|---|
| Surgical neck fracture | 91 |
| Presence of displacement | 56 |
| Presence of angulation | 84 |
| Residual angulation at follow up | 55 |
| Worsened angulation | 25 |
Collected over 4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Children With Proximal Humerus Fractures | — | 0/118 (0%) | 0/118 (0%) |
| Age, Categorical(Participants) | Children With Proximal Humerus Fractures |
|---|---|
| <=18 years | 118 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Children With Proximal Humerus Fractures |
|---|---|
| Mean | 12 (10 to 18) |
| Sex: Female, Male(Participants) | Children With Proximal Humerus Fractures |
|---|---|
| Female | 56 |
| Male | 62 |
| Region of Enrollment(Participants) | Children With Proximal Humerus Fractures |
|---|---|
| United Kingdom | 118 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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NHS Tayside