The Study of the Nonunion of Long Tubular Bone | NCT02338258

Studies
The Study of the Nonunion of Long Tubular Bone

NCT02338258

Sponsor

Beijing Jishuitan Hospital

Status

Unknown status

Last Update Posted

Jan 14, 2015Estimated

Enrollment

82Estimated

Phase

Phase 1

Conditions

Diaphyses

Interventions

Anti-rotational plate
Exchanged Intramedullary nailing

Countries

China

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Dec 26, 2014

First Submission Date that Met QC Criteria

Jan 11, 2015

First Posted Date

Jan 14, 2015Estimated

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

Jan 11, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of the long tubular bone after treatment of Intramedallery nailing

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The Anti-rotational plate group	Experimental	The method was used to control the rotational unstabilization at the fracture site	Device: Anti-rotational plate Device: Exchanged Intramedullary nailing
Exchanged Intramedullary nailing group	Placebo Comparator	the method Provided the axial and rotational stability	Device: Exchanged Intramedullary nailing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-rotational plate	Device		The Anti-rotational plate group
Exchanged Intramedullary nailing

Measure	Description	Time Frame
The healing rate		9 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient who had the nonunion of long tubular bone
The patient who was the age of 14 ~ 65 years old.
The patient who complete the follow-up conditions.
The patient who has independent behavior ability.
The patient who volunteered for signed informed consent

Exclusion Criteria:

Infectious nonunion of the long turubar bone
Pathological fracture.
The immune system disease.
Cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bosong BS zhang, MD	Contact	+8613621219567	+86	zhangbosong@sina.com

Overall Officials

Name	Affiliation	Role
Bosong Zhang, MD	Jishuitan hospital in Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The orthopaedic Trauma center of Jishuitan Hospital in Beijing	Recruiting	Beijing	Beijing Municipality	730000	China