- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02372838
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
Intervention / Treatment
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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