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OpenTrials
Completed

NCT Number: NCT02372825

Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without treatment with the vascularized iliac crest transfer,

Exclusion criteria

for the cross-sectional assessment:

  • deceased,
  • below-knee amputation,
  • permanent non-union

Treatment and study plan

Reconstructive Surgery

Procedure

Reconstructive surgery with the free iliac crest flap

Primary outcomes

  1. Visual Analogue Scale Heel and Ankle (VAS FA)

    Time frame: 2-26 years

    Assesses the function of the heel and ankle

  2. Oswestry Disability Index (ODI)

    Time frame: 2-16 years

    Assesses the function of the donor site

  3. The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument

    Time frame: 2-26 years

    Assesses the HRQoL

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Eastern Finland
  • University of Helsinki

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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