The Study of the Nonunion of Long Tubular Bone

Beijing Jishuitan Hospital

Status and phase: Unknown; Phase 1

Conditions: Diaphyses

Treatments: Device: Exchanged Intramedullary nailing; Device: Anti-rotational plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02338258

Z141107002514086

Details and patient eligibility

About

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

Enrollment: 82 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

The Anti-rotational plate group

Experimental group

Description:

The method was used to control the rotational unstabilization at the fracture site

Treatment:

Device: Exchanged Intramedullary nailing

Device: Anti-rotational plate

Exchanged Intramedullary nailing group

Placebo Comparator group

Description:

the method Provided the axial and rotational stability

Treatment:

Device: Exchanged Intramedullary nailing