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

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

Study Locations

    • Beijing
      • Beijing, Beijing, China, 730000
        • Recruiting
        • The orthopaedic Trauma center of Jishuitan Hospital in Beijing
        • Contact:

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:

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

Exclusion Criteria:

  1. Infectious nonunion of the long turubar bone
  2. Pathological fracture.
  3. The immune system disease.
  4. 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.

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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