Condition category
Musculoskeletal Diseases
Date applied
05/04/2020
Date assigned
04/05/2020
Last edited
08/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Some broken bones do not heal even when they get the best surgical or nonsurgical treatment. In some cases, certain risk factors make it more likely that a bone will fail to heal. When a broken bone fails to heal it is called a "nonunion." Incomplete fracture healing may lead to chronic nonunion, thus determining fracture healing is the basic issue in clinical treatment. However, there are no validated molecules in the blood (biomarkers) for p chronic nonunion. In this study, bioinformatics analysis combined with the experimental verification strategy was used to identify blood biomarkers for chronic nonunion.

Who can participate?
Patients diagnosed with open fractures of long bone and defined non-union.

What does the study involve?
Participants will provide a single blood sample for analysis.

What are the possible benefits and risks of participating?
None explaected.

Where is the study run from?
Xuanwu Hospital of Capital Medical University (China)

When is the study starting and how long is it expected to run for?
August 2018 to October 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Limin Liu
xwllm2019@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Limin Liu

ORCID ID

http://orcid.org/0000-0001-9167-9079

Contact details

Xuanwu Hospital of the Capital Medical University
Changchun Street No.45
Beijing
100053
China
+86-010-8319-8277
xwllm2019@sina.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Bioinformatic analysis and experimental identification of blood biomarkers for chronic nonunion

Acronym

Study hypothesis

Incomplete fracture healing may lead to chronic nonunion, thus determining fracture healing is the basic issue in clinical treatment. However, there were no validated early diagnose biomarkers for assessing chronic nonunion. In this study, bioinformatics analysis combined with the experimental verification strategy was used to identify blood biomarkers for chronic nonunion.

Ethics approval

Approved 13/07/2018, Ethics Committee of Xuanwu Hospital, Capital Medical University (Chuangchun Street No.45, Beijing, China, 100053; +86-010-8319-9270; xwkyethics@163.com), ref: XW-2018-135.

Study design

Observational

Primary study design

Observational

Secondary study design

Ecological study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Nonunion of open fractures of long bone

Intervention

Patients admitted to the Department of Orthopedics of Xuanwu Hospital between August 2018 and July 2019, are enrolled in this study. The group is categorized into the Healed and Nonunion groups, according to the FDA diagnostic criteria amendment. The FDA defines nonunion as a fractured bone that has not completely healed within 9 months following injury and without signs of healing for at least 3 months.
In this study, 9 months was chosen as the time point to define the nonunion.

Bioinformatics analysis combined with the experimental verification strategy was used to identify blood biomarkers for chronic nonunion. First, chronic nonunion differential expressed genes were identified by microarray data analysis. Second, Dipsaci Radix (DR), traditional Chinese medicine for fracture treatment, was used to screen the target genes. Third, the drug-compound-target-disease network was determined, and the biomarker genes were obtained. Finally, the potential blood biomarkers were verified by ELISA and qPCR methods.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dipsaci Radix

Primary outcome measure

Biomarkers verified by ELISA and qPCR methods from a blood sample taken at a single time point

Secondary outcome measures

None

Overall trial start date

01/05/2018

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients diagnosed with open fractures of long bone and defined nonunion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Total final enrolment

55

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/08/2018

Recruitment end date

31/07/2019

Locations

Countries of recruitment

China

Trial participating centre

Xuanwu Hospital of Capital Medical University
Changchun Street No.45
Beijing
100053
China

Sponsor information

Organisation

Xuan Wu Hospital of the Capital Medical University

Sponsor details

Changchun Street No.45
Beijing
100053
China
+86-138-1051-7806
edmond_pku@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

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:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32503597/ (added 08/06/2020)

Publication citations

Additional files

Editorial Notes

08/06/2020: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 04/05/2020: Trial’s existence confirmed by Ethics Committee of Xuanwu Hospital.