Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Completed

• Conditions: Limb Salvage

• Registration Number: NCT02372825
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-26
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Uusimaa, Finland