Limb SalvageNCT02372825
Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction
An observational study of Limb Salvage, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Limb Salvage
- What is being tested?
- Reconstructive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2014to Feb 2015
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Thirteen men patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.
Who may be able to join
- Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.
Who cannot join
- 1) Patients without treatment with the vascularized iliac crest transfer,
- deceased,
- below-knee amputation,
- permanent non-union
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Limb Salvage
- Being tested
- Reconstructive surgery
- Keywords
- Free iliac crest transfer, Bone reconstruction, Ankle reconstruction, Heel reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstructive surgeryProcedure or surgery
Reconstructive surgery with the free iliac crest flap
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Heel and Ankle (VAS FA)
Assesses the function of the heel and ankle
Measured: 2-26 years
Oswestry Disability Index (ODI)
Assesses the function of the donor site
Measured: 2-16 years
The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument
Assesses the HRQoL
Measured: 2-26 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb SalvageStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, University of Eastern Finland
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD, PhD, Study director, Department of plastic and reconstructive surgery, HUCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372825
- Sponsor's protocol ID
- 343/13/03/02/13/2
- Status last verified
- May 2015
- First submitted
- 17 Feb 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction
- ClinicalTrials.gov ID
- NCT02372825
- Acronym / sponsor ID
- 343/13/03/02/13/2
- Conditions
- Limb Salvage
- Keywords
- Free iliac crest transfer, Bone reconstruction, Ankle reconstruction, Heel reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, University of Eastern Finland
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirteen men patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.
Key inclusion criteria (1 listed)
- Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.
Key exclusion criteria (4 listed)
- 1) Patients without treatment with the vascularized iliac crest transfer,
- deceased,
- below-knee amputation,
- permanent non-union
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconstructive surgeryReconstructive surgery with the free iliac crest flap | Procedure or surgery | – |
Primary outcome
Visual Analogue Scale Heel and Ankle (VAS FA)
Time frame: 2-26 years
Assesses the function of the heel and ankle
Oswestry Disability Index (ODI)
Time frame: 2-16 years
Assesses the function of the donor site
The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument
Time frame: 2-26 years
Assesses the HRQoL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkki J Tukiainen, MD, PhD study director
Department of plastic and reconstructive surgery, HUCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Salvage, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Heel and Ankle (VAS FA) (time frame: 2-26 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.