The Study of the Nonunion of Long Tubular Bone

Phase 1

• Conditions: Diaphyses
• Interventions: Device: Anti-rotational plate; Device: Exchanged Intramedullary nailing

• Registration Number: NCT02338258
• Lead Sponsor: Beijing Jishuitan Hospital

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 available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-26
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-11
• Last Update Submitted: 2015-01-11
• Study First Posted: 2015-01-14
• Last Update Posted: 2015-01-14
• Primary Completion: 2016-09
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Anti-rotational plate group	Anti-rotational plate	The method was used to control the rotational unstabilization at the fracture site
The Anti-rotational plate group	Exchanged Intramedullary nailing	The method was used to control the rotational unstabilization at the fracture site
Exchanged Intramedullary nailing group	Exchanged Intramedullary nailing	the method Provided the axial and rotational stability

Primary Outcome Measures

Name	Time	Method
The healing rate	9 months

Trial Locations

Locations (1)

The orthopaedic Trauma center of Jishuitan Hospital in Beijing; 🇨🇳 Beijing, Beijing, China