NCT02372838

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

February 21, 2015

Last Update Submit

August 17, 2015

Conditions

Limb Salvage

Outcome Measures

Primary Outcomes (1)

  • The long-term results are good

    The long-term outcomes are assessed and good results gained.

    10-20 years

Secondary Outcomes (3)

  • Disabilities of the Arm, Shoulder and Hand questionnaire

    10-20 years

  • the 15-Dimensions health-related quality of life instrument

    10-20 years

  • Lower Extremity Functional Scale

    10-20 years

Interventions

Microvascular fibula bone transferPROCEDURE

Reconstructive surgery with a microvascular bone flap

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No upper extremity free fibular transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Erkki J. Tukiainen, MD, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.S.

Study Record Dates

First Submitted

February 21, 2015

First Posted

February 26, 2015

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08