NCT06361290Completed
Diaphyseal Reconstruction of Malignant Tumors in Children
Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas. The objective of oncological resection is local control of the disease. Excision of the entire tumor should make it possible to maintain good function of the limb, minimizing morbidity, and promoting acceptance by the patient. Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane technique, the Vascularized Fibula and Vascularized Fibula associated with an Allograft. Until today, no reconstruction technique in children has proven its superiority over another and no decision-making algorithm for therapeutic care has been determined based on the importance of the bone resection and the affected segment in diaphyseal tumor reconstruction surgery of the lower limb. The aim of the present research is to compare the three techniques concerning the consolidation aspect, the reoperation rates, the rates of bone complications, septic, and the functional results by the study of the medical files of approximately 90 patients operated between 1986 and 2017.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 91 (actual)
- First submitted
- 28 Mar 2024
- Start date
- 30 May 2024
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Childhood cancers
- NCT number
- NCT06361290
What you commit to
- Study type: Observational
- Participants enrolled: 91
- From 30 May 2024 to the primary completion date, 30 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patient over 18 years old at the time of surgery
Other
- Patient who died within 5 years or who had a follow-up of less than 5 years following the reconstruction procedure
- Patient with joint damage
- Patient who had an isolated reconstruction of the fibula
- Opposition of adult patients/holders of parental authority of minor patients to whom the study information note was sent, to the use of the patient's medical data for the study
Who the study is looking for
- Patient under 18 years old with a malignant bone tumor of the lower limb (femur or tibia), diaphyseal or metaphyseal-diaphyseal
- Patients operated between 1986 and 2017 for a diaphyseal resection of the tumor with biological reconstruction using either Induced Membrane, Vascularized Fibula and Vascularized Fibula associated with an Allograft
- Patient with a minimum follow-up of 5 years
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.