Plain English Summary
Background and study aims
The humerus is the long bone that connects the shoulder to the elbow. When it is fractured, it is usually fixed using a less invasive surgical procedure called deltoid muscle splitting. However, this procedure has concerns about its effectiveness in aging people and complex fractures. The efficacy of the using a ‘locking plate’ needs to be evaluated using the anterolateral (located in front and to one side) deltoid splitting approach and specially examine the effect depending on the patient’s age, gender and fracture type. The aim of this study is to evaluate the efficacy of a humeral locking plate using the anterolateral deltoid splitting approach and to specifically examine the effect of patient age, gender and fracture pattern on surgical outcomes.
Who can participate?
Adults aged 36 to 77 years old who have humerus fractures.
What does the study involve?
This is a case review study of proximal humerus fractures that are treated surgically with the Locking compression plate from 2009 to 2011.The researchers gathered data about the surgery, reviewed record and radiographs, as well as gender, age, fracture type and their follow up. This is done to assess the surgical outcomes to this procedure.
What are the possible benefits and risks of participating?
There are no benefits or risks with participating.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
December 2008 to June 2017
Who is funding the study?
Chang Gung Medical Foundation (Taiwan)
Who is the main contact?
Dr Alvin Chao-Yu Chen
alvinchen@cgmh.org.tw
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alvin Chao-Yu Chen
ORCID ID
http://orcid.org/0000-0003-0111-490X
Contact details
Chang Gung Memorial Hospital
5th Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan
+886 3281200 3882
alvinchen@cgmh.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
No. 201700826B0
Study information
Scientific title
Influence of age, gender, and radiographic features on the deltoid splitting approach for surgical osteosynthesis in displaced proximal humerus fractures
Acronym
Study hypothesis
Examining the influence of the surgical approach for management of displaced proximal humerus fractures and to specifically examine the impact of patient age and fracture pattern on the outcomes.
Ethics approval
Institutional Review Board of Chang Gung Memorial Hospital, 07/06/2017, ref: No. 201700826B0
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Examining the influence of patient demographics on the influence of surgical approach in displaced proximal humerus fractures
Intervention
This study retrospectively evaluated cases of unilateral proximal humerus fractures that were treated surgically with the Locking Compression Plate (LCP), as per the Neer classification criteria at our institute between 2009 and 2011.
Institutional review board approval was obtained to perform a review of patients’ records and radiographs; informed consent was obtained from 132 patients with displaced proximal humerus fractures. All these cases of proximal humerus fractures either met the indications for operative treatment outlined by Neer or were considered unstable when tested for passive motion with an image intensifier.
Those with pathological fractures, head split fractures, open fractures, fractures with primary neurovascular damage, multiple fractures, and cases lost to follow-up are excluded from the study. Forty-two patients, who underwent anterolateral deltoid splitting surgery, are selected for a retrospective matched pairs analysis according to their age (younger than 60 years vs. older than 60 years), gender, and fracture type with a minimum follow-up of 24 months.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Fracture healing is measured using the data from the cases.
Secondary outcome measures
1. Functional outcomes are measured using the data from the cases
2. Radio is measured using the data from the cases
Overall trial start date
01/12/2008
Overall trial end date
30/06/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Displaced proximal humerus fractures. All these cases of proximal humerus fractures either met the indications for operative treatment outlined by Neer or were considered unstable when tested for passive motion with an image intensifier.
2. Aged 36 to 77 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients with pathological fractures
2. Head split fractures
3. Open fractures
4. Fractures with primary neurovascular damage
5. Multiple fractures
6. Cases lost to follow-up were excluded from the study
Recruitment start date
01/01/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital
5th
Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital
Sponsor details
5th
Fu-Hsin Street
Keishan District
Taoyuan
333
Taiwan
+886 3281200 3882
alvinchen@cgmh.org.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Medical Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plans to publish our reports in peer-reviewed journals this year.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Alvin Chao-Yu Chen, MD at alvinchen@cgmh.org.tw
Intention to publish date
31/12/2017
Participant level data
Available on request
Results - basic reporting
Publication summary