Deltoid splitting approach for surgical osteosynthesis in displaced proximal humerus fractures
| ISRCTN | ISRCTN75494532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75494532 |
| Protocol serial number | No. 201700826B0 |
| Sponsor | Chang Gung Memorial Hospital |
| Funder | Chang Gung Medical Foundation |
- 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
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
Scientific
Chang Gung Memorial Hospital
5th Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan
 ORCID ID |
0000-0003-0111-490X |
|---|---|
| Phone | +886 3281200 3882 |
| alvinchen@cgmh.org.tw |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational case-control study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Influence of age, gender, and radiographic features on the deltoid splitting approach for surgical osteosynthesis in displaced proximal humerus fractures |
| Study objectives | 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(s) | Institutional Review Board of Chang Gung Memorial Hospital, 07/06/2017, ref: No. 201700826B0 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Fracture healing is measured using the data from the cases. |
| Key secondary outcome measure(s) |
1. Functional outcomes are measured using the data from the cases |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Fu-Hsin Street
Kweishan District
Taoyuan
333
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/08/2018: Publication reference added
11/08/2017: Internal review.
