NCT00846261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

4.9 years

First QC Date

February 17, 2009

Last Update Submit

March 3, 2009

Conditions

TraumaOrthopedic Surgery Complications

Keywords

infectedIlizarov

Outcome Measures

Primary Outcomes (1)

  • Achive wounds close and bone union

    3 years

Study Arms (1)

Ilzarov

EXPERIMENTAL
Device: Use it to treatment bone nonunion (Ilzarov)

Interventions

Use it to treatment bone nonunion (Ilzarov)DEVICE

Detect the variation of limb lengthening

Also known as: Ilizarov, Trauma
Ilzarov

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patient noncooperation and an age of less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310029, China

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Ilizarov Technique

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsBone LengtheningSurgical Procedures, Operative

Study Officials

  • Qiang Zheng, doctor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

January 1, 2002

Primary Completion

December 1, 2006

Study Completion

January 1, 2008

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

CN(1)