Reconstruction of Extensive Upper Extremity Long Bone Def... | NCT02372838

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

NCT02372838

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Limb Salvage

Interventions

Microvascular fibula bone transfer

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Feb 21, 2015

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Feb 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microvascular fibula bone transfer	Procedure	Reconstructive surgery with a microvascular bone flap

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Disabilities of the Arm, Shoulder and Hand questionnaire	Assesses the function of the reconstructed limb	10-20 years
the 15-Dimensions health-related quality of life instrument	The 15-Dimensions assesses the health-related quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J. Tukiainen, MD, PhD	Helsinki University Central Hospital	Study Director

Locations

Not provided