The Study of the Nonunion of Long Tubular Bone

NCT ID: NCT02338258

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diaphyses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Anti-rotational plate group

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

Group Type EXPERIMENTAL

Anti-rotational plate

Intervention Type DEVICE

Exchanged Intramedullary nailing

Intervention Type DEVICE

Exchanged Intramedullary nailing group

the method Provided the axial and rotational stability

Group Type PLACEBO_COMPARATOR

Exchanged Intramedullary nailing

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anti-rotational plate

Intervention Type DEVICE

Exchanged Intramedullary nailing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xianzhi Ma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bosong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Jishuitan hospital in Beijing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The orthopaedic Trauma center of Jishuitan Hospital in Beijing

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bosong BS zhang, MD

Role: CONTACT

+8613621219567 ext. +86

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

xianzhi XZ Ma, MD

Role: primary

+8615201542942

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Z141107002514086

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Allograft vs. Autograft Nonunion
NCT07310082 NOT_YET_RECRUITING NA