Postoperative ComplicationsNCT02265991
Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation
An observational study of Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Fibula Explantation
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jun 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with informed consent and that will undergo mandible resection and reconstruction via free fibula flap at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.
Who may be able to join
- Planned continuity interrupting mandible resection
- Planned mandible reconstruction with free fibula flap
- Informed consent
- Procedure performed at University Medical Center Hamburg Eppendorf
Who cannot join
- Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
- Musculosceletal pain at the time of study enrollment
About this study
Official title: Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.
Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.
Read the detailed description
27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.
- Conditions
- Postoperative Complications
- Being tested
- Fibula Explantation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibula ExplantationProcedure or surgery
Also called Free fibula flap, autologous fibula transfer
surgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Esslinger Fitness Index
Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP
Measured: 1 day before fibula transplantation and 8.3 months postoperatively on average
Secondary outcomes (3)
AOFAS Score
Objective and Subjective Score for functionality and pathology of the ankle region
Measured: 1 day before fibula transplantation and 8.3 months postoperatively on average
Balance Test
Functional Assessment on Leonardo Mechanograph GFRP, measures the patients' stability
Measured: 1 day before fibula transplantation and 8.3 months postoperatively on average
Range of Motion
Measuring Ankle Motion before and after surgery with a goniometer
Measured: 1 day before fibula transplantation and 8.3 months postoperatively on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Rendenbach, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265991
- Sponsor's protocol ID
- UKEppendorfMKG
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.
- ClinicalTrials.gov ID
- NCT02265991
- Acronym / sponsor ID
- UKEppendorfMKG
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Oct 2014 (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.
Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.
Detailed description
27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with informed consent and that will undergo mandible resection and reconstruction via free fibula flap at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.
Key inclusion criteria (4 listed)
- Planned continuity interrupting mandible resection
- Planned mandible reconstruction with free fibula flap
- Informed consent
- Procedure performed at University Medical Center Hamburg Eppendorf
Key exclusion criteria (2 listed)
- Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
- Musculosceletal pain at the time of study enrollment
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 |
|---|---|---|
| Fibula ExplantationAlso: Free fibula flap, autologous fibula transfersurgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues | Procedure or surgery | – |
Primary outcome
Change in Esslinger Fitness Index
Time frame: 1 day before fibula transplantation and 8.3 months postoperatively on average
Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP
3 secondary outcomes
AOFAS Score
Time frame: 1 day before fibula transplantation and 8.3 months postoperatively on average
Balance Test
Time frame: 1 day before fibula transplantation and 8.3 months postoperatively on average
Range of Motion
Time frame: 1 day before fibula transplantation and 8.3 months postoperatively on average
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 16 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf.
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 4 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 16 Oct 2014. 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?
Change in Esslinger Fitness Index (time frame: 1 day before fibula transplantation and 8.3 months postoperatively on average). 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 16 Oct 2014.