Reconstructive Surgical ProcedureNCT02369991
Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique
An observational study of Reconstructive Surgical Procedure, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Reconstructive Surgical Procedure
- What is being tested?
- Reconstructive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2014to Feb 2015
- How long will I take part?
- 5 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport
Who may be able to join
- Age over 15 years.
- Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.
Who cannot join
- Deceased.
- Patients under 15 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique: a Cross-sectional Study of Long-term Outcomes
This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.
Read the detailed description
A retrospective review of hospital records was conducted to chart the clinical and operational characteristics of patient. Patients current condition is assessed by applying two function-related (Disabilities of the Arm, Hand and Shoulder, DASH; Lower Extremity Functional Scale, LEFS) and a health-related quality of life (the 15-dimensions, 15D) questionnaires. The patients received the questionnaires by mail. A written informed consent was obtained from the participants. The obtained data was computerized and analyzed.
- Conditions
- Reconstructive Surgical Procedure
- Being tested
- Reconstructive surgery
- Keywords
- latissimus dorsi flap, bone transport, bone reconstruction, tibia, tibial fracture
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstructive surgeryProcedure or surgery
Patients were treated with free latissimus dorsi flap and bone transport technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH)
Assesses the function of the donor site
Measured: 10-25 years
The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.
Assesses the HRQoL
Measured: 10-25 years
Lower Extremity Functional Scale (LEFS)
Assesses the function of the reconstructed limb
Measured: 10-25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 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 Reconstructive Surgical ProcedureStudies 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
- 9 participants (actual)
- Target duration
- 5 Years
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, PhD, MD, Study director, Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369991
- Sponsor's protocol ID
- 343/13/03/02/2013/4
- Status last verified
- May 2015
- First submitted
- 18 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
- Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique: a Cross-sectional Study of Long-term Outcomes
- ClinicalTrials.gov ID
- NCT02369991
- Acronym / sponsor ID
- 343/13/03/02/2013/4
- Conditions
- Reconstructive Surgical Procedure
- Keywords
- latissimus dorsi flap, bone transport, bone reconstruction, tibia, tibial fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 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
- 24 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 results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.
Detailed description
A retrospective review of hospital records was conducted to chart the clinical and operational characteristics of patient. Patients current condition is assessed by applying two function-related (Disabilities of the Arm, Hand and Shoulder, DASH; Lower Extremity Functional Scale, LEFS) and a health-related quality of life (the 15-dimensions, 15D) questionnaires. The patients received the questionnaires by mail. A written informed consent was obtained from the participants. The obtained data was computerized and analyzed.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport
Key inclusion criteria (2 listed)
- Age over 15 years.
- Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.
Key exclusion criteria (2 listed)
- Deceased.
- Patients under 15 years of age.
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 surgeryPatients were treated with free latissimus dorsi flap and bone transport technique | Procedure or surgery | – |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 10-25 years
Assesses the function of the donor site
The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.
Time frame: 10-25 years
Assesses the HRQoL
Lower Extremity Functional Scale (LEFS)
Time frame: 10-25 years
Assesses the function of the reconstructed limb
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, PhD, MD study director
Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.
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 Reconstructive Surgical Procedure, 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 2 inclusion and 2 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?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: 10-25 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.