Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Limb Salvage Clinical Trial

Official title:

Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372825
• Other study ID #: 343/13/03/02/13/2
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: May 12, 2015
• Start date: June 2014
• Est. completion date: February 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

1. deceased,

2. below-knee amputation,

3. permanent non-union

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Limb Salvage

Intervention

Procedure:
• Reconstructive surgery
Reconstructive surgery with the free iliac crest flap

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Helsinki University, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Heel and Ankle (VAS FA)	Assesses the function of the heel and ankle	2-26 years	No
Primary	Oswestry Disability Index (ODI)	Assesses the function of the donor site	2-16 years	No
Primary	The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument	Assesses the HRQoL	2-26 years	No