Bone FractureNCT03244969
Bone Healing Study
An observational study of Bone Fracture, run by Kazan Federal University at 1 site in Russia.
Trial summary
The aim of the research is to identify structural tissue changes in the early fracture hematomas. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Bone Fracture
- How many people
- 0 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2017to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fractures of the upper and lower extremities underwent surgical bone recunstruction.
Who may be able to join
- Patients with fractures of the upper and lower extremities
- Patients for whom the surgical bone reconstruction are indicated
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Granulation Tissue Formation in the Early Fracture Hematoma
The aim of the research is to identify structural tissue changes in the early fracture hematomas.
Read the detailed description
The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.
- Conditions
- Bone Fracture
- Keywords
- Hematoma fracture, angiogenesis, bone formation
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulation tissue formation
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Aug 2017
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Study was registered in another clinicaltrials.gov entry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazan Federal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Mavlikeev, Kazan Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244969
- Sponsor's protocol ID
- hematoma-2017
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Granulation Tissue Formation in the Early Fracture Hematoma
- ClinicalTrials.gov ID
- NCT03244969
- Acronym / sponsor ID
- hematoma-2017
- Conditions
- Bone Fracture
- Keywords
- Hematoma fracture, angiogenesis, bone formation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was registered in another clinicaltrials.gov entry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kazan Federal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the research is to identify structural tissue changes in the early fracture hematomas.
Detailed description
The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fractures of the upper and lower extremities underwent surgical bone recunstruction.
Key inclusion criteria (2 listed)
- Patients with fractures of the upper and lower extremities
- Patients for whom the surgical bone reconstruction are indicated
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Granulation tissue formation
Time frame: 23 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fracture, run by Kazan Federal University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granulation tissue formation (time frame: 23 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021; AzTrials last refreshed its copy on 4 Nov 2026.