NCT05641597

Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bone Reconstruction by Free Fibula Flap

Interventions

Type	Name	Description
OTHER	Actimetric measurement	Evaluation during 7 days "in real life condition Carried out during the pre-operative evaluation (M0), the post-operative evaluation (M1) and the post-operative evaluation (M6)
OTHER	Evaluation of plantar flexion, dorsal flexion and ankle eversion forces	Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
OTHER	Assessment of static and dynamic balance and quality of life	Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
OTHER	Functional gait assessment (TM6)	Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments

Timeline

• Start date: 2022-11-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-12-07
• Last updated: 2024-02-20

Locations

1 site across 1 country: France