Bone Healing Study | NCT03244969

Studies
Bone Healing Study

NCT03244969

Sponsor

Kazan Federal University

Status

Withdrawn

Last Update Posted

Sep 5, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bone Fracture

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was registered in another clinicaltrials.gov entry

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Oct 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Aug 7, 2017

First Submission Date that Met QC Criteria

Aug 7, 2017

First Posted Date

Aug 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mikhail Mavlikeev, aspirant of the morphology department, Kazan Federal UniversityPrincipal Investigator

Lead Sponsor

Kazan Federal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Measure	Description	Time Frame
Granulation tissue formation		23 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with fractures of the upper and lower extremities
Patients for whom the surgical bone reconstruction are indicated

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with fractures of the upper and lower extremities underwent surgical bone recunstruction.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Igor Plaksa		Moscow		119333	Russia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided