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Functional Impact of Postoperative Vascularized Free Fibula Flap Harvesting Repair Surgery. Prospective Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Dijon Bourgogne
RECRUITING
Dijon
Contact Information
Primary
David GUILLIER
david.guillier@chu-dijon.fr
0380293757
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 35
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov