Clinical outcomes investigation in ulna coronoid fractures with elbow instability
| ISRCTN | ISRCTN21770659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21770659 |
| Protocol serial number | none |
| Sponsor | Chang Gung Memorial Hospital-Linkou |
| Funder | Chang Gung Memorial Hospital-Linkou |
- Submission date
- 01/03/2018
- Registration date
- 05/04/2018
- Last edited
- 04/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The coronoid process is a projection from the front of one of the bones in the arm that forms part of the elbow. Fracturing this can lead to instability of the elbow, which was traditionally thought to be classified by the size of the fracture. However recent studies have shown that the location of the fracture is also needed to help analyse the injury. The anteromedial facet is a central part of the coronoid process and fractures here typically vary, so the surgical approach to treat them is critical.
This study aims to report the surgical outcomes of participants with this type of fracture, by analysing their previous hospital records and results to suggest the best surgical approach.
Who can participate?
Adults with a fractured ulnar coronoid
What does the study involve?
All participants undergo surgery to fix their broken bone. The broken bone is reduced or put back in place, then an internal device is placed on the bone to hold it together. This may be screws, plates or pins depending on the injury. Participants attend follow up appointments 2 weeks, 3 months, 6 months, 1 year and 2 years after the operation where they undergo disability evaluation and X-ray imaging.
What are the possible benefits and risks of participating?
There are not any direct benefits or risks for those taking part in the study.
Where is the study run from?
Chang Gung Memorial Hospital-Linkou (Taiwan)
When is the study starting and how long is it expected to run for?
January 2007 – December 2017
Who is funding the study?
Chang Gung Memorial Hospital – Linkou (Taiwan)
Who is the main contact?
Dr Alvin Chao-Yu Chen (Scientific)
alvinchen@cgmh.org.tw
Contact information
Scientific
5th, Fu-Shin St.
Kweishan District
Taoyuan
333
Taiwan
 ORCID ID |
0000-0003-0111-490X |
|---|---|
| Phone | +886 3 3281200 |
| alvinchen@cgmh.org.tw |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Restrospective reviews on surgical outcomes of ulnar anteromedial facet fractures |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Anteromedial fractures of the ulnar coronoid process: correlation between surgical outcomes and radiographic findings |
| Study objectives | This study aims to report the surgical outcomes of a consecutive case series and suggest an optimal surgical approach through a retrospective analysis of the surgical and radiographic findings of AMF fracture dislocation. |
| Ethics approval(s) | Chang Gung Institutional Review Board, 11/09/2017, ref: IRB 201701326B0 |
| Health condition(s) or problem(s) studied | Fracture of forearm |
| Intervention | Open reduction and internal fixation of ulnar coronoid fractures is performed for all patients by the same surgeon. Fixation methods and implants are dependent on the fracture patterns including plate, screw, pin and wire and suture anchors. All participants attend regular outpatient clinic follow up appointments at 2 weeks, 3 months, 6 months, 1 year and 2 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinical functional outcomes are measured using the Mayo Elbow Performance Score (MEPs) and Shortened Disability of the Arm and Shoulder and Hand (quickDASH) scores two years after the operation. |
| Key secondary outcome measure(s) |
Radiographic correlation with surgical approach and clinical results are assessed by an orthopaedic trauma surgeon and an elbow surgeon using retrospective review of elbow radiographs two years after the operation. |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Displaced anteromedial facet fracture of ulnar coronoid with instability |
| Key exclusion criteria | 1. Prior injury or surgery of the ipsilateral arm |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 28/02/2014 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kweishan District
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 and analysed during the current study can be provided upon request from Alvin CY Chen (alvinchen@cgmh.org.tw) in Microsoft Word text files. It is available for10 years after surgery for each participant. Consents from participants was obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
