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Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

NCT ID: NCT02372825

Last Updated: 2015-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a formidable challenge for the reconstructive surgeon. These defects can be treated with the vascularized iliac crest transfer. The purpose of this study is to assess the reliability and the long-term outcomes of free iliac crest flap transfer for these indications.

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Detailed Description

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Thirteen patients were included in this study. Data was collected retrospectively from the patient records. The study design included three outcome measures to assess the clinical long-term outcomes. These were the Visual Analogue Scale Foot and Ankle (VAS FA), the Oswestry Disability Index (ODI), and the 15-dimensions (15D) health-related quality of life (HRQoL) instrument. The data was collected with postal approach and a written informed consent obtained from the seven participants.

Conditions

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Limb Salvage

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Interventions

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Reconstructive surgery

Reconstructive surgery with the free iliac crest flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

Exclusion Criteria

1\) Patients without treatment with the vascularized iliac crest transfer,


1. deceased,
2. below-knee amputation,
3. permanent non-union
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jussi Repo

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erkki J Tukiainen, MD, PhD

Role: STUDY_DIRECTOR

Department of plastic and reconstructive surgery, HUCS

Locations

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Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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343/13/03/02/13/2

Identifier Type: -

Identifier Source: org_study_id

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