Bone Reconstruction by Free Fibula Flap
Conditions
Brief 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. 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
Interventions
OTHERActimetric measurement
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)
OTHEREvaluation of plantar flexion, dorsal flexion and ankle eversion forces
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
OTHERAssessment of static and dynamic balance and quality of life
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
OTHERFunctional gait assessment (TM6)
Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum isometric force of plantar flexion of the foot on a dynamometer | Change from pre-op and 6 months post-op |
Countries
France
Contacts
Primary ContactDavid GUILLIER
Outcome results
None listed