Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05641597

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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