Clinical outcomes investigation in ulna coronoid fractures with elbow instability

ISRCTN	ISRCTN21770659
DOI	https://doi.org/10.1186/ISRCTN21770659
Secondary identifying numbers	none

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Alvin Chao-Yu Chen
Scientific

5th, Fu-Shin St.
Kweishan District
Taoyuan
333
Taiwan

ORCID ID	0000-0003-0111-490X
Phone	+886 3 3281200
Email	alvinchen@cgmh.org.tw

Study information

Study design	Restrospective reviews on surgical outcomes of ulnar anteromedial facet fractures
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a 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	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 study start date	01/01/2007
Completion date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Chang Gung Memorial Hospital-Linkou

5th, Fu-Shin St.
Kweishan District
333
Taiwan

Sponsor information

Chang Gung Memorial Hospital-Linkou
Hospital/treatment centre

5th, Fu-Shin St.
Kweishan District
Taoyuan
333
Taiwan

Phone	+886 3 3281200
Email	alvinchen@cgmh.org.tw
"ROR"	https://ror.org/02dnn6q67

Funders

Funder type

Hospital/treatment centre

Chang Gung Memorial Hospital-Linkou

No information available

Results and Publications

Intention to publish date	31/08/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
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.