Deltoid splitting approach for surgical osteosynthesis in displaced proximal humerus fractures

ISRCTN ISRCTN75494532
DOI https://doi.org/10.1186/ISRCTN75494532
Secondary identifying numbers No. 201700826B0
Submission date
14/07/2017
Registration date
26/07/2017
Last edited
17/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Alvin Chao-Yu Chen
Scientific

Chang Gung Memorial Hospital
5th Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan

ORCiD logoORCID ID 0000-0003-0111-490X
Phone +886 3281200 3882
Email alvinchen@cgmh.org.tw

Study information

Study designObservational case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInfluence of age, gender, and radiographic features on the deltoid splitting approach for surgical osteosynthesis in displaced proximal humerus fractures
Study objectivesExamining 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(s)Institutional Review Board of Chang Gung Memorial Hospital, 07/06/2017, ref: No. 201700826B0
Health condition(s) or problem(s) studiedExamining the influence of patient demographics on the influence of surgical approach in displaced proximal humerus fractures
InterventionThis 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 typeProcedure/Surgery
Primary outcome measureFracture healing is measured using the data from the cases.
Secondary outcome measures1. Functional outcomes are measured using the data from the cases
2. Radio is measured using the data from the cases
Overall study start date01/12/2008
Completion date30/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2009
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Chang Gung Memorial Hospital
5th
Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan

Sponsor information

Chang Gung Memorial Hospital
Hospital/treatment centre

5th
Fu-Hsin Street
Keishan District
Taoyuan
333
Taiwan

Phone +886 3281200 3882
Email alvinchen@cgmh.org.tw
Website www.cgmh.org.tw
ROR logo "ROR" https://ror.org/02verss31

Funders

Funder type

Hospital/treatment centre

Chang Gung Medical Foundation

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlans to publish our reports in peer-reviewed journals this year.
IPD sharing planThe 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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2017 Yes No

Editorial Notes

17/08/2018: Publication reference added
11/08/2017: Internal review.