NCT02372825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

February 17, 2015

Last Update Submit

May 12, 2015

Conditions

Limb Salvage

Keywords

Free iliac crest transferBone reconstructionAnkle reconstructionHeel reconstruction

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Reconstructive surgeryPROCEDURE

Reconstructive surgery with the free iliac crest flap

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \) Patients without treatment with the vascularized iliac crest transfer,
  • deceased,
  • below-knee amputation,
  • permanent non-union

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 0, Finland

Location

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Erkki J Tukiainen, MD, PhD

    Department of plastic and reconstructive surgery, HUCS

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 26, 2015

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

FI(1)