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

Limb Salvage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372838
• Other study ID #: 343/13/03/02/13/3
• Status: Completed
• Phase: N/A
• First received: February 21, 2015
• Last updated: August 17, 2015
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Limb Salvage

Intervention

Procedure:
• Microvascular fibula bone transfer
Reconstructive surgery with a microvascular bone flap

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The long-term results are good	The long-term outcomes are assessed and good results gained.	10-20 years	No
Secondary	Disabilities of the Arm, Shoulder and Hand questionnaire	Assesses the function of the reconstructed limb	10-20 years	No
Secondary	the 15-Dimensions health-related quality of life instrument	The 15-Dimensions assesses the health-related quality of life	10-20 years	No
Secondary	Lower Extremity Functional Scale	Assesses the function of the donor site	10-20 years	No