Actively Recruiting
Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.
Led by Centre Hospitalier Universitaire Dijon · Updated on 2024-02-20
35
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients eligible for bone reconstruction with a free fibula flap
- Age 18 years or older
- 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
You will not qualify if you...
- Person who is not affiliated or not a beneficiary of a social security system
- Person subject to a legal protection measure (curatorship, guardianship)
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
D
David GUILLIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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