Using a universal surgical device for jaw reconstruction
Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
This study tests a new surgical device to see if it can make jaw reconstruction easier and safer for patients needing this type of surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06238076 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a universal surgical device designed for mandibular reconstruction using a fibula free flap. The device aims to enhance surgical precision, reduce operation time, and minimize patient morbidity by providing a custom surgical guide. The research will assess whether this universal guide can successfully facilitate the reconstruction process compared to traditional methods. Participants will be patients admitted for mandibular reconstruction who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are patients admitted for mandibular fibula free flap reconstruction who are insured under the French social security system.
Not a fit: Patients requiring lateral mandibular reconstruction without symphysis reconstruction or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient and safer surgical procedures for patients requiring mandibular reconstruction.
How similar studies have performed: While custom surgical guides have been used successfully in the past, this study explores a novel universal guide approach, which has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment * Patients insured under the French social security system * Free and informed consent Exclusion Criteria: * Lateral mandibular reconstruction without symphysis reconstruction * Legally incompetent * Inclusion in another protocol of research , involving mandibular reconstruction * Pregnant or breastfeeding women
Where this trial is running
Toulouse
- CHU Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Alice PREVOST, MD — University Hospital, Toulouse
- Study coordinator: Alice PREVOST, MD
- Email: prevost.a@chu-toulouse.fr
- Phone: +335 61 77 95 43
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.