Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap

August 17, 2015 updated by: Jussi Repo, Helsinki University Central Hospital

Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap: a Cross-sectional Study of Long-term Outcomes

This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.

Study Overview

Status

Completed

Conditions

Detailed Description

The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.

Study Type

Observational

Enrollment (Actual)

13

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty patients with upper extremity long bone bone defect treated with a microvascular fibula transfer. Population aged below 90 years.

Description

Inclusion Criteria:

  • All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital.

Exclusion Criteria:

  • No upper extremity free fibular transfer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The long-term results are good
Time Frame: 10-20 years
The long-term outcomes are assessed and good results gained.
10-20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder and Hand questionnaire
Time Frame: 10-20 years
Assesses the function of the reconstructed limb
10-20 years
the 15-Dimensions health-related quality of life instrument
Time Frame: 10-20 years
The 15-Dimensions assesses the health-related quality of life
10-20 years
Lower Extremity Functional Scale
Time Frame: 10-20 years
Assesses the function of the donor site
10-20 years

Collaborators and Investigators

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

Investigators

  • Study Director: Erkki J. Tukiainen, MD, PhD, Helsinki University Central Hospital

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 21, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 343/13/03/02/13/3

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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