Evaluating the impact of reconstructive surgery using a free fibula flap
Functional Impact of Postoperative Vascularized Free Fibula Flap Harvesting Repair Surgery. Prospective Pilot Study
This study is testing how well reconstructive surgery using a free fibula flap can improve movement and quality of life for patients after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05641597 on ClinicalTrials.gov |
What this trial studies
This study aims to objectively quantify the functional repercussions of reconstructive surgery using a vascularized free fibula flap, particularly focusing on muscular and locomotor functions. It will assess various parameters such as plantar flexion, dorsal flexion, ankle eversion forces, static and dynamic balance, and overall quality of life. By employing actimetric measurements and functional gait assessments, the study seeks to identify specific therapeutic targets for personalized postoperative rehabilitation. This is the first study of its kind to evaluate these functional impacts in detail.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for bone reconstruction with a free fibula flap at the Dijon University Hospital.
Not a fit: Patients with significant prior impairments in walking due to musculoskeletal or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients undergoing complex bone reconstruction, enhancing their recovery and quality of life.
How similar studies have performed: While this approach is innovative and has not been previously tested, similar studies in functional rehabilitation have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Person who is not affiliated or not a beneficiary of a social security system * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a legal protection measure * 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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: David GUILLIER
- Email: david.guillier@chu-dijon.fr
- Phone: 0380293757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.