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NCT Number: NCT06361290

Diaphyseal Reconstruction of Malignant Tumors in Children

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.

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Key information

Conditions

Childhood Malignant Tumors of Lower Limbs Neoplasms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Armand-Trousseau, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection from hospital medical records

Other

Data collection from hospital medical records of patients concerning the 5 years following the resection of the tumor.

Primary outcomes

  1. Duration of bone consolidation period

    Time frame: 5 years

    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

  1. Rate of surgical re-intervention

    Time frame: 5 years

    The rates of septic, transfusional and immediate intraoperative complications of each surgery will be compared. The recovery rate for sepsis will also be considered. Neurological and vascular complications will also be compared. The total number of interventions will be counted.

  2. Short- and long-term complication rates

    Time frame: 5 years

    Bone complications will be noted: fractures, pseudarthrosis, axial deviation and stress fractures will be noted and compared between the techniques. Secondary axial deviation and lower limb length inequalities will also be the subject of a comparative study in long-term follow-up.

    Other rates of septic or other complications will also be noted.

  3. Long-term functional results

    Time frame: 5 years

    Long-term functional results will be described: joint range of motion is measured clinically at the hip, knee and ankle and reported in degrees from standardized anatomical positions, a VAS assessment of pain is performed, length inequality is measured radiologically and reported in millimeters on based on the non-operated limb, an MSTS score is performed (Musculoskeletal Tumor Society Rating Scale), an Enneking score is also performed.

  4. Relationship between radiotherapy and biological reconstruction result

    Time frame: 5 years

    To demonstrate the effect of adjuvant oncological treatments, the type of tumor and adjuvant and neoadjuvant treatment will be taken into account. In particular the presence or absence of post-operative radiotherapy.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts

Acronym: RDTM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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