Clinical trial NCT06361290: Diaphyseal Reconstruction of Malignant Tumors in Children
Official title: Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Malignant Tumors of Lower Limbs
Keywords: Diaphyseal reconstruction techniques
Induced membrane technique
Vascularized fibula
Vascularized fibula grafts
Malignant tumors
Childhood
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 91
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Historical cohort of all patients treated for a malignant bone tumor of the lower limb between 1986 and 2017 in the AP-HP Necker-Enfants Malades or Armand Trousseau hospitals, part of the oncological follow-up of which was possibly carried out at the Institut Gustave Roussy or the Institut Curie.

Brief summary: 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.

Detailed description: Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas.

The diagnosis of a bone tumor is based on the clinical, radiological and biopsy comparison.

The main issue in the treatment of malignant tumors is the vital prognosis and secondarily the functional prognosis. Historically, primary malignant bone tumors have been treated by amputation.

The tumor resection, thanks to advances in chemotherapy since the 1970s, today shows survival rates identical to radical techniques. The goal of surgery is local control of the disease. The excision of the entire tumor should make it possible to maintain good function of the limb, in particular to minimize morbidity, and promote acceptance by the patient. Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane, the Vascularized Fibula and the 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 study is to compare the 3 diaphyseal reconstruction techniques in the context of malignant tumors in children, and to fill this gap, by providing a decision tree allowing this choice to be made. The comparison concerns 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. The hypothesis of the study is that one of the techniques offers better consolidation rates in major resections, and that adjuvant oncological treatments modify the results that can be expected from these different techniques.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of bone consolidation period
timeFrame: 5 years
Secondary outcomes:
measure: Rate of surgical re-intervention
timeFrame: 5 years
measure: Short- and long-term complication rates
timeFrame: 5 years
measure: Long-term functional results
timeFrame: 5 years
measure: Relationship between radiotherapy and biological reconstruction result
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Armand-Trousseau
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Edouard Haumont, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eric Mascard, MD
role: STUDY_DIRECTOR
References:
citation: Stiller 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.
citation: Arndt 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.
citation: Hameed 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.
citation: Whelan 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.
citation: Le 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.
citation: Hariri 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.