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

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00846261
First received: February 17, 2009
Last updated: March 3, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Trauma
Orthopedic Surgery Complications
 Device: Use it to treatment bone nonunion (Ilzarov)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • Achive wounds close and bone union [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: January 2002
Study Completion Date: January 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ilzarov Device: Use it to treatment bone nonunion (Ilzarov)
Detect the variation of limb lengthening
Other Names:
  • Ilizarov
  • Trauma

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846261

Locations
China, Zhejiang
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
  More Information

No publications provided

Responsible Party: Department of Orthopedics, 2nd Affiliated Hospital, School of Medicine,, Zhejiang University
ClinicalTrials.gov Identifier: NCT00846261     History of Changes
Other Study ID Numbers: Z2-001
Study First Received: February 17, 2009
Last Updated: March 3, 2009
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang University:
infected
Ilizarov

ClinicalTrials.gov processed this record on September 26, 2012