The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique

NCT ID: NCT00846261

Last Updated: 2009-03-04

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-01-31

Brief Summary

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

In this retrospective study, the investigators evaluated the clinical and functional results of infected nonunion of the long bone with soft-tissue defects treated simultaneously with Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to find out whether that the internal bone transport with external fixator combining open dressing change is a valuable method to treatment for those patients with infected bone nonunion and poor condition of the soft tissue such as sinus, skin defect.

Detailed Description

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

From January 2002 to now, totally 22 patients (18 males, 4 females) were underwent internal bone transport for infected nonunion in the long bone with soft-tissue defects. The mean age of the patients was 36.5 years (range, 19 to 57). The infected nonunion occurred on the femur in 1 patients, the tibia in 21 patients. The hybrid mono-lateral limb reconstruction external fixator was used, combined with bone transport. The results were evaluated by the classification of the Association for the Study and Application of the Method of Ilizarov (ASAMI) which divided into bone and functional categories

Conditions

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

Trauma Orthopedic Surgery Complications

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Ilzarov

Group Type EXPERIMENTAL

Use it to treatment bone nonunion (Ilzarov)

Intervention Type DEVICE

Detect the variation of limb lengthening

Interventions

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

Use it to treatment bone nonunion (Ilzarov)

Detect the variation of limb lengthening

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ilizarov Trauma

Eligibility Criteria

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

Inclusion Criteria

* Patients with infected nonunion of long bone with soft tissue defects or sinus, without systemic illness that could affect their immunologic status (e.g., AIDS, diabetes mellitus, liver cirrhosis).

Exclusion Criteria

* Patient noncooperation and an age of less than 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Odense University Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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

Zhejiang University

Principal Investigators

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

Qiang Zheng, doctor

Role: STUDY_DIRECTOR

Department of Orthopedics, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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

China

Other Identifiers

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

Z2-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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