Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alvin Chao-Yu Chen
ORCID ID
http://orcid.org/0000-0003-0111-490X
Contact details
5th
Fu-Shin St.
Kweishan District
Taoyuan
333
Taiwan
+886 3 3281200
alvinchen@cgmh.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
none
Study information
Scientific title
Anteromedial fractures of the ulnar coronoid process: correlation between surgical outcomes and radiographic findings
Acronym
Study hypothesis
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
Chang Gung Institutional Review Board, 11/09/2017, ref: IRB 201701326B0
Study design
Restrospective reviews on surgical outcomes of ulnar anteromedial facet fractures
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Displaced anteromedial facet fracture of ulnar coronoid with instability
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Prior injury or surgery of the ipsilateral arm
Recruitment start date
01/02/2007
Recruitment end date
28/02/2014
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital-Linkou
5th, Fu-Shin St.
Kweishan District
333
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital-Linkou
Sponsor details
5th
Fu-Shin St.
Kweishan District
Taoyuan
333
Taiwan
+886 3 3281200
alvinchen@cgmh.org.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Memorial Hospital-Linkou
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
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.
Intention to publish date
31/08/2018
Participant level data
Available on request
Results - basic reporting
Publication summary