- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02338258
The Study of the Nonunion of Long Tubular Bone
January 11, 2015 updated by: Xianzhi Ma, Beijing Jishuitan Hospital
The Prospective、Randomized、Comparative Clinical Study About the Two Operation Methods Between Anti-rotational Plate Group and Exchanged Intramedullary Nailgroup to Treat the Nonunion of Long Tubular Bone After Intramedullary Nail Fixation
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bosong BS zhang, MD
- Phone Number: +86 +8613621219567
- Email: zhangbosong@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 730000
- Recruiting
- The orthopaedic Trauma center of Jishuitan Hospital in Beijing
-
Contact:
- xianzhi XZ Ma, MD
- Phone Number: +8615201542942
- Email: 870248900@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The Anti-rotational plate group
The method was used to control the rotational unstabilization at the fracture site
|
|
Placebo Comparator: Exchanged Intramedullary nailing group
the method Provided the axial and rotational stability
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The healing rate
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bosong Zhang, MD, Jishuitan hospital in Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
December 26, 2014
First Submitted That Met QC Criteria
January 11, 2015
First Posted (Estimate)
January 14, 2015
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 11, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Z141107002514086
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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