Loading clinical trials...
Loading clinical trials...
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chu Dijon Bourgogne
Dijon, France
Start Date
November 15, 2022
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
February 20, 2024
35
ESTIMATED participants
Actimetric measurement
OTHER
Evaluation of plantar flexion, dorsal flexion and ankle eversion forces
OTHER
Assessment of static and dynamic balance and quality of life
OTHER
Functional gait assessment (TM6)
OTHER
Lead Sponsor
Centre Hospitalier Universitaire Dijon
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions