Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Malignant Tumors of Lower Limbs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection from hospital medical records | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients under 18 years of age treated between 1986 and 2017 for malignant bone tumors of the lower limb (femur or tibia), diaphyseal or metaphyseal-diaphyseal and having benefited from diaphyseal resection of the tumor with biological reconstruction by either Membrane Induced, Fibula Vascularized and or Vascularized Fibula associated with an Allograft and having had a minimum follow-up of 5 years.
- interventionNames
- Other: Data collection from hospital medical records
Primary outcomes (1)
- measure
- Duration of bone consolidation period
- timeFrame
- 5 years
- description
- Radiological consolidation times based on follow-up radiographs will be compared to the size of the bone resections in order to establish the healing index. The deadlines for providing support to members will also be collected.
Secondary outcomes (4)
- measure
- Rate of surgical re-intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 over 18 years old at the time of surgery * 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
References
Publications (6)
- BACKGROUNDStiller CA, Bielack SS, Jundt G, Steliarova-Foucher E. Bone tumours in European children and adolescents, 1978-1997. Report from the Automated Childhood Cancer Information System project. Eur J Cancer. 2006 Sep;42(13):2124-35. doi: 10.1016/j.ejca.2006.05.015. PMID 16919776
- BACKGROUNDArndt CA, Crist WM. Common musculoskeletal tumors of childhood and adolescence. N Engl J Med. 1999 Jul 29;341(5):342-52. doi: 10.1056/NEJM199907293410507. No abstract available. PMID 10423470
- BACKGROUNDHameed M, Dorfman H. Primary malignant bone tumors--recent developments. Semin Diagn Pathol. 2011 Feb;28(1):86-101. doi: 10.1053/j.semdp.2011.02.002. PMID 21675380
- BACKGROUNDWhelan JS, Jinks RC, McTiernan A, Sydes MR, Hook JM, Trani L, Uscinska B, Bramwell V, Lewis IJ, Nooij MA, van Glabbeke M, Grimer RJ, Hogendoorn PC, Taminiau AH, Gelderblom H. Survival from high-grade localised extremity osteosarcoma: combined results and prognostic factors from three European Osteosarcoma Intergroup randomised controlled trials. Ann Oncol. 2012 Jun;23(6):1607-16. doi: 10.1093/annonc/mdr491. Epub 2011 Oct 19. PMID 22015453
- BACKGROUNDLe Nen D, Dubrana F, Hu W, Prud'homme M, Lefè;vre C. Fibula vascularisée. Techniques, indications en orthopédie et traumatologie. EMC - Tech Chir - Orthopédie - Traumatol. 2006;1(1):1-10.
- BACKGROUNDHariri A, Mascard E, Atlan F, Germain MA, Heming N, Dubousset JF, Wicart P. Free vascularised fibular graft for reconstruction of defects of the lower limb after resection of tumour. J Bone Joint Surg Br. 2010 Nov;92(11):1574-9. doi: 10.1302/0301-620X.92B11.23832. PMID 21037355