Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique

May 12, 2015 updated by: Jussi Repo, Helsinki University Central Hospital

Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique: a Cross-sectional Study of Long-term Outcomes

This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective review of hospital records was conducted to chart the clinical and operational characteristics of patient. Patients current condition is assessed by applying two function-related (Disabilities of the Arm, Hand and Shoulder, DASH; Lower Extremity Functional Scale, LEFS) and a health-related quality of life (the 15-dimensions, 15D) questionnaires. The patients received the questionnaires by mail. A written informed consent was obtained from the participants. The obtained data was computerized and analyzed.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport

Description

Inclusion Criteria:

  • Age over 15 years.
  • Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.

Exclusion Criteria:

  • Deceased.
  • Patients under 15 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: 10-25 years
Assesses the function of the donor site
10-25 years
The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.
Time Frame: 10-25 years
Assesses the HRQoL
10-25 years
Lower Extremity Functional Scale (LEFS)
Time Frame: 10-25 years
Assesses the function of the reconstructed limb
10-25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Erkki J. Tukiainen, PhD, MD, Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 343/13/03/02/2013/4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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