Diaphyseal Reconstruction of Malignant Tumors in Children (RDTM)

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Childhood Malignant Tumors of Lower Limbs

Treatments

Other: Data collection from hospital medical records

Study type

Observational

Funder types

Other

Identifiers

NCT06361290
APHP231703

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

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.
Treatment:
Other: Data collection from hospital medical records

Trial contacts and locations

2

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Central trial contact

Hélène Morel; Edouard Haumont, MD

Data sourced from clinicaltrials.gov

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