The Study of the Nonunion of Long Tubular Bone

• Sponsor: Beijing Jishuitan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02338258
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diaphyses	Device: Anti-rotational plate; Device: Exchanged Intramedullary nailing	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The Anti-rotational plate group The method was used to control the rotational unstabilization at the fracture site	Device: Anti-rotational plate; Device: Exchanged Intramedullary nailing
Placebo Comparator: Exchanged Intramedullary nailing group the method Provided the axial and rotational stability	Device: Exchanged Intramedullary nailing

Outcome Measures

Primary Outcome Measures

1. The healing rate [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The orthopaedic Trauma center of Jishuitan Hospital in Beijing	Beijing	Beijing	China	730000

Sponsors and Collaborators

• Beijing Jishuitan Hospital

Investigators

• Principal Investigator: Bosong Zhang, MD, Jishuitan hospital in Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xianzhi Ma, , Beijing Jishuitan Hospital
• ClinicalTrials.gov Identifier: NCT02338258
• Other Study ID Numbers: Z141107002514086
• First Posted: Jan 14, 2015
• Last Update Posted: Jan 14, 2015
• Last Verified: Jan 1, 2015

Study Results

No Results Posted as of Jan 14, 2015