Role of Free Iliac Crest Flap in Heel and Ankle Reconstru... | NCT02372825

Studies
Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

NCT02372825

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

May 14, 2015Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Limb Salvage

Interventions

Reconstructive surgery

Countries

Finland

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

May 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 17, 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

May 12, 2015

Last Update Posted Date

May 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jussi Repo, Researcher, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
University of Helsinki	OTHER
University of Eastern Finland	OTHER

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

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reconstructive surgery	Procedure	Reconstructive surgery with the free iliac crest flap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale Heel and Ankle (VAS FA)	Assesses the function of the heel and ankle	2-26 years
Oswestry Disability Index (ODI)	Assesses the function of the donor site	2-16 years
The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument	Assesses the HRQoL	2-26 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Exclusion criteria for the cross-sectional assessment:

deceased,
below-knee amputation,
permanent non-union

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Thirteen men patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J Tukiainen, MD, PhD	Department of plastic and reconstructive surgery, HUCS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	0	Finland

Intervention Browse Module

MeSH Terms

ID	Term
D019651	Plastic Surgery Procedures

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

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Browse Branches

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