Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/03/2018
Date assigned
05/04/2018
Last edited
04/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measure

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 (if study stopped)

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes