Limb SalvageNCT02372838
Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap
An observational study of Limb Salvage, run by Helsinki University Central Hospital.
Trial summary
This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Limb Salvage
- What is being tested?
- Microvascular fibula bone transfer
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Feb 2015
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twenty patients with upper extremity long bone bone defect treated with a microvascular fibula transfer. Population aged below 90 years.
Who may be able to join
- All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital.
Who cannot join
- No upper extremity free fibular transfer
About this study
Official title: Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap: a Cross-sectional Study of Long-term Outcomes
This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.
Read the detailed description
The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.
- Conditions
- Limb Salvage
- Being tested
- Microvascular fibula bone transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular fibula bone transferProcedure or surgery
Reconstructive surgery with a microvascular bone flap
What is being measured
The primary outcome is the main question the study is designed to answer.
The long-term results are good
The long-term outcomes are assessed and good results gained.
Measured: 10-20 years
Secondary outcomes (3)
Disabilities of the Arm, Shoulder and Hand questionnaire
Assesses the function of the reconstructed limb
Measured: 10-20 years
the 15-Dimensions health-related quality of life instrument
The 15-Dimensions assesses the health-related quality of life
Measured: 10-20 years
Lower Extremity Functional Scale
Assesses the function of the donor site
Measured: 10-20 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.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J. Tukiainen, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372838
- Sponsor's protocol ID
- 343/13/03/02/13/3
- Status last verified
- Aug 2015
- First submitted
- 21 Feb 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Extensive Upper Extremity Long Bone Defects With a Microvascular Fibula Flap: a Cross-sectional Study of Long-term Outcomes
- ClinicalTrials.gov ID
- NCT02372838
- Acronym / sponsor ID
- 343/13/03/02/13/3
- Conditions
- Limb Salvage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- 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.
This study assesses the long-term functional outcomes of upper extremity long bone defects treated with the free fibula bone transfer.
Detailed description
The study design entails a retrospective review of hospital records and a cross-sectional assessment using patient-reported outcome measures. The purpose of this study is to evaluate the reliability, complications and flap survival rate as well as the long-term functional and health-related quality of life results in patients with upper extremity long bone defect reconstructed using a microvascular fibula bone transfer.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty patients with upper extremity long bone bone defect treated with a microvascular fibula transfer. Population aged below 90 years.
Key inclusion criteria (1 listed)
- All patients of upper extremity long bone bone defect treated with a microvascular fibula transfer in Helsinki University Central Hospital.
Key exclusion criteria (1 listed)
- No upper extremity free fibular transfer
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 |
|---|---|---|
| Microvascular fibula bone transferReconstructive surgery with a microvascular bone flap | Procedure or surgery | – |
Primary outcome
The long-term results are good
Time frame: 10-20 years
The long-term outcomes are assessed and good results gained.
3 secondary outcomes
Disabilities of the Arm, Shoulder and Hand questionnaire
Time frame: 10-20 years
the 15-Dimensions health-related quality of life instrument
Time frame: 10-20 years
Lower Extremity Functional Scale
Time frame: 10-20 years
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 19 Aug 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
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Salvage, run by Helsinki University Central Hospital.
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 1 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The long-term results are good (time frame: 10-20 years). 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 19 Aug 2015.