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

Sponsor
Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT00846261
Collaborator
Odense University Hospital (Other)
22
Enrollment
1
Location
1
Arm
72
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Use it to treatment bone nonunion (Ilzarov)
 Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ilzarov

Device: Use it to treatment bone nonunion (Ilzarov)
Detect the variation of limb lengthening
Other Names:
  • Ilizarov
  • Trauma

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Achive wounds close and bone union [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310029

    Sponsors and Collaborators

    • Zhejiang University
    • Odense University Hospital

    Investigators

    • Study Director: Qiang Zheng, doctor, Department of Orthopedics, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00846261
    Other Study ID Numbers:
    • Z2-001
    First Posted:
    Feb 18, 2009
    Last Update Posted:
    Mar 4, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    infected
    Ilizarov

    Study Results

    No Results Posted as of Mar 4, 2009