Minimally invasive treatment for high-risk ankle fractures
Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients? A Monocentric Case Series
This study tests a new, less invasive way to treat high-risk ankle fractures to see if it helps adults with skin issues recover better than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (La Tronche) |
| Trial ID | NCT06518265 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the treatment of high-risk ankle fractures using a minimally invasive method known as locked fibula nails. It aims to evaluate the outcomes of this technique compared to traditional open reduction and fixation methods, particularly in patients with compromised skin integrity. The study will include adult patients with unstable ankle fractures and high skin risk, assessing their recovery through standard preoperative and postoperative imaging. By analyzing these cases, the study seeks to identify which patients benefit most from this innovative approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with unstable ankle fractures and high skin risk factors.
Not a fit: Patients who are pregnant, breastfeeding, or cognitively impaired may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes and reduced complications for patients with high-risk ankle fractures.
How similar studies have performed: Previous studies have shown promising results with similar minimally invasive techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient at the time of injury * Unstable fracture of one or both ankles: tri-malleolar fracture, distal quarter of the leg, tibial pilon. * High skin risk (acute traumatic tissue injury associated or not with an open fracture evaluated according to the Oestern and Tscherne classification, chronic skin disease such as lipodermatosclerosis, lymphedema, varicose or arterial ulcer and skin atrophy secondary to corticosteroid therapy long course compromising the healing of a longitudinal incision next to the fibula). * Standard preoperative x-ray image (ankle face and profile) * Standard image post-operative x-rays (ankle face and profile) * No opposition to participation in the study. Exclusion Criteria: * Pregnant, breastfeeding women. * Subject under guardianship, curatorship, deprived of liberty or under the protection of justice. * Subject who are cognitively incapable of answering the questionnaire.
Where this trial is running
La Tronche
- Grenoble Alpes university Hospital,La tronche — La Tronche, France (Recruiting)
Study contacts
- Study coordinator: Mehdi PI BOUDISSA, Pr
- Email: MBoudissa@chu-grenoble.fr
- Phone: 0033476769693
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.