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Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372825
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : May 14, 2015
Sponsor:
Collaborators:
University of Helsinki
University of Eastern Finland
Information provided by (Responsible Party):
Jussi Repo, 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.

Condition or disease Intervention/treatment
Limb Salvage Procedure: Reconstructive surgery

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 7 participants
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thirteen men patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372825


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 0
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
University of Eastern Finland
Investigators
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Study Director: Erkki J Tukiainen, MD, PhD Department of plastic and reconstructive surgery, HUCS
Additional Information:

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Responsible Party: Jussi Repo, Researcher, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02372825    
Other Study ID Numbers: 343/13/03/02/13/2
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Jussi Repo, Helsinki University Central Hospital:
Free iliac crest transfer
Bone reconstruction
Ankle reconstruction
Heel reconstruction