Management of displaced tibial fractures in children and adolescents
Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents: Should Osteosynthesis Be Favored From the Start?
This study looks at how well different treatments for broken leg bones work in children and teens to see if surgery is better than using a cast.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06503718 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the management of closed diaphyseal displaced tibial fractures in pediatric patients. It aims to compare traditional treatment methods, such as cast immobilization, with newer surgical interventions like osteosynthesis. The study will analyze outcomes from patients treated at the University Hospital in Strasbourg over a specified period, reviewing their medical data after more than six months post-treatment. The goal is to provide insights into the effectiveness of these treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are minors under 18 years old who have sustained a closed diaphyseal displaced tibial fracture and received treatment at the University Hospital in Strasbourg.
Not a fit: Patients with non-displaced fractures, open fractures, or those who have opted out of data reuse for research purposes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for pediatric tibial fractures, leading to better recovery outcomes.
How similar studies have performed: While traditional methods have shown good long-term results, the shift towards surgical intervention is relatively novel and not extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minor subject (under 18 years old) * Subject treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months * Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. Exclusion criteria: * Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. * Non-displaced and/or displaced fracture not located at the level of the tibial diaphysis * Open fracture * Incomplete or unusable file
Where this trial is running
Strasbourg
- Service de Chirurgie Pédiatrique - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Philippe GICQUEL, MD
- Email: Philippe.Gicquel@chru-strasbourg.fr
- Phone: 33 3 88 12 82 65
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.