Identifying molecules in the blood associated with long term healing problems in long bone fractures
| ISRCTN | ISRCTN13271153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13271153 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Xuan Wu Hospital of the Capital Medical University |
| Funder | Investigator initiated and funded |
- Submission date
- 05/04/2020
- Registration date
- 04/05/2020
- Last edited
- 08/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Xuanwu Hospital of the Capital Medical University
Changchun Street No.45
Beijing
100053
China
 ORCID ID |
0000-0001-9167-9079 |
|---|---|
| Phone | +86-010-8319-8277 |
| xwllm2019@sina.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational |
| Secondary study design | Ecological study |
| Study type | Participant information sheet |
| Scientific title | Bioinformatic analysis and experimental identification of blood biomarkers for chronic nonunion |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Dipsaci Radix |
| Primary outcome measure(s) |
Biomarkers verified by ELISA and qPCR methods from a blood sample taken at a single time point |
| Key secondary outcome measure(s) |
None |
| Completion date | 31/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 55 |
| Key inclusion criteria | Patients diagnosed with open fractures of long bone and defined nonunion |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/07/2019 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100053
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/06/2020 | 08/06/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
