Bone Reconstruction by Free Fibula FlapFIBULAMNCT05641597
Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.
A study testing Actimetric measurement, Evaluation of plantar flexion, dorsal flexion and ankle eversion forces and Assessment of static and dynamic balance and quality of life in people with Bone Reconstruction by Free Fibula Flap, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The fibula is a leg bone that can be used in complex bone reconstruction by reconstructive surgery. This innovative surgical procedure is increasingly used in complex facial (mandibular) reconstructions following cancer and trauma involving a bone segment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Reconstruction by Free Fibula Flap
- What is being tested?
- Actimetric measurement, Evaluation of plantar flexion, dorsal flexion and ankle eversion forces and Assessment of static and dynamic balance and quality of life
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 17 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients eligible for bone reconstruction with a free fibula flap
- Age ≥ 18 years
- Procedure scheduled in the plastic and maxillofacial surgery department of the Dijon University Hospital
- Willingness to comply with the protocol requirements
- Person having given oral, free and informed consent
Who cannot join
- Person who is not affiliated or not a beneficiary of a social security system
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Pregnant, parturient or breastfeeding woman
- Major who is incapable or unable to give oral consent
- Minor
Show all 10Show fewer
- Indication for bone reconstruction of a lower limb (e.g. femur) or pelvis
- Musculoskeletal or neurological disorders causing significant prior impairment of walking (whatever the etiology)
- Cognitive disorders that prevent the proper understanding of instructions and the completion of questionnaires
- Non operated patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Impact of Postoperative Vascularized Free Fibula Flap Harvesting Repair Surgery. Prospective Pilot Study
The fibula is a leg bone that can be used in complex bone reconstruction by reconstructive surgery. This innovative surgical procedure is increasingly used in complex facial (mandibular) reconstructions following cancer and trauma involving a bone segment. Following this surgery, chronic pain and post-operative complications can occur, with a functional impact on locomotion, leading to instability, ankle stiffness and a risk of falls. The causes of functional deficits following surgery remain complex and difficult to objectivate by clinical examination alone. However, these deficits need to be better evaluated to develop specific therapeutic targets that will allow the implementation of a personalized postoperative rehabilitation. At present, no study has been performed to objectively quantify the short- and medium-term functional repercussions of the operation.
This study proposes, for the first time, to quantify the repercussions on muscular and locomotor functions as well as the quality of life after reconstructive surgery by transfer of a free vascularized fibula flap in the short and medium term (1 month and 6 months postoperatively).
This is a biomedical, interventional study, which will take place on the Technological Investigation Platform (PIT) located on the garden level of the Rehabilitation Center (C2R) of the Dijon Bourgogne University Hospital, 35 participants will be included in this study over a period of 36 months. For this study, you will be followed for about 7 months, during 3 obligatory visits
- Conditions
- Bone Reconstruction by Free Fibula Flap
- Being tested
- Actimetric measurement, Evaluation of plantar flexion, dorsal flexion and ankle eversion forces, Assessment of static and dynamic balance and quality of life, Functional gait assessment (TM6)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actimetric measurementOther
Evaluation during 7 days "in real life condition Carried out during the pre-operative evaluation (M0), the post-operative evaluation (M1) and the post-operative evaluation (M6)
Evaluation of plantar flexion, dorsal flexion and ankle eversion forcesOther
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
Assessment of static and dynamic balance and quality of lifeOther
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
Functional gait assessment (TM6)Other
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum isometric force of plantar flexion of the foot on a dynamometer
Measured: Change from pre-op and 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start15 Nov 2022
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Why it stopped: The enrollment rate was insufficient due to a smaller-than-expected proportion of eligible patients and difficulties in coordinating the schedule of visits with the scheduling of surgical procedures, thereby limiting enrollment opportunities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Reconstruction by Free Fibula FlapStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641597
- Sponsor's protocol ID
- GUILLIER AOI 2021
- Acronym
- FIBULAM
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impact of Postoperative Vascularized Free Fibula Flap Harvesting Repair Surgery. Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT05641597
- Acronym / sponsor ID
- FIBULAM / GUILLIER AOI 2021
- Conditions
- Bone Reconstruction by Free Fibula Flap
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment rate was insufficient due to a smaller-than-expected proportion of eligible patients and difficulties in coordinating the schedule of visits with the scheduling of surgical procedures, thereby limiting enrollment opportunities
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 7 Dec 2022 (actual)
- 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.
The fibula is a leg bone that can be used in complex bone reconstruction by reconstructive surgery. This innovative surgical procedure is increasingly used in complex facial (mandibular) reconstructions following cancer and trauma involving a bone segment. Following this surgery, chronic pain and post-operative complications can occur, with a functional impact on locomotion, leading to instability, ankle stiffness and a risk of falls. The causes of functional deficits following surgery remain complex and difficult to objectivate by clinical examination alone. However, these deficits need to be better evaluated to develop specific therapeutic targets that will allow the implementation of a personalized postoperative rehabilitation. At present, no study has been performed to objectively quantify the short- and medium-term functional repercussions of the operation.
This study proposes, for the first time, to quantify the repercussions on muscular and locomotor functions as well as the quality of life after reconstructive surgery by transfer of a free vascularized fibula flap in the short and medium term (1 month and 6 months postoperatively).
This is a biomedical, interventional study, which will take place on the Technological Investigation Platform (PIT) located on the garden level of the Rehabilitation Center (C2R) of the Dijon Bourgogne University Hospital, 35 participants will be included in this study over a period of 36 months. For this study, you will be followed for about 7 months, during 3 obligatory visits
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients eligible for bone reconstruction with a free fibula flap
- Age ≥ 18 years
- Procedure scheduled in the plastic and maxillofacial surgery department of the Dijon University Hospital
- Willingness to comply with the protocol requirements
- Person having given oral, free and informed consent
Key exclusion criteria (10 listed)
- Person who is not affiliated or not a beneficiary of a social security system
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Pregnant, parturient or breastfeeding woman
- Major who is incapable or unable to give oral consent
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 |
|---|---|---|
| Actimetric measurementEvaluation during 7 days "in real life condition Carried out during the pre-operative evaluation (M0), the post-operative evaluation (M1) and the post-operative evaluation (M6) | Other | – |
| Evaluation of plantar flexion, dorsal flexion and ankle eversion forcesPerformed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments | Other | – |
| Assessment of static and dynamic balance and quality of lifePerformed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments | Other | – |
| Functional gait assessment (TM6)Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments | Other | – |
Primary outcome
Maximum isometric force of plantar flexion of the foot on a dynamometer
Time frame: Change from pre-op and 6 months post-op
Results and safety
The study was stopped early (reason given: The enrollment rate was insufficient due to a smaller-than-expected proportion of eligible patients and difficulties in coordinating the schedule of visits with the scheduling of surgical procedures, thereby limiting enrollment opportunities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actimetric measurement, Evaluation of plantar flexion, dorsal flexion and ankle eversion forces and Assessment of static and dynamic balance and quality of life in people with Bone Reconstruction by Free Fibula Flap, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Oct 2026. 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 France. 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 was stopped early (reason given: The enrollment rate was insufficient due to a smaller-than-expected proportion of eligible patients and difficulties in coordinating the schedule of visits with the scheduling of surgical procedures, thereby limiting enrollment opportunities). Results are not available in the source record.
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?
Maximum isometric force of plantar flexion of the foot on a dynamometer (time frame: Change from pre-op and 6 months post-op). 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 26 Oct 2026.