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NCT05641597
Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.
Conditions: Bone Reconstruction by Free Fibula Flap
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 35
Sponsor: Centre Hospitalier Universitaire Dijon
Location: France
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
Eligibility Criteria
Inclusion Criteria:All patients eligible for bone reconstruction with a free fibula flapAge ≥ 18 yearsProcedure scheduled in the plastic and maxillofacial surgery department of the Dijon University HospitalWillingness to comply with the protocol requirementsPerson having given oral, free and informed consentExclusion Criteria:Person who is not affiliated or not a beneficiary of a social security systemPerson subject to a legal protection measure (curatorship, guardianship)Person subject to a legal protection measurePregnant, parturient or breastfeeding womanMajor who is incapable or unable to give oral consentMinorIndication for bone reconstruction of a lower limb (e.g.
femur) or pelvisMusculoskeletal 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 questionnairesNon operated patient
Source: ClinicalTrials.gov (NCT05641597). StuddyBuddy aggregates publicly available trial information.