Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361290
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-28
Brief Title:
Diaphyseal Reconstruction of Malignant Tumors in Children
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDTM
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None