Childhood Malignant Tumors of Lower LimbsRDTMNCT06361290
Diaphyseal Reconstruction of Malignant Tumors in Children
An observational study of Childhood Malignant Tumors of Lower Limbs, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Childhood Malignant Tumors of Lower Limbs
- What is being tested?
- Data collection from hospital medical records
- How many people
- 91 participants
- Where
- 2 sitesFrance
- Study dates
- 30 May 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Armand-Trousseau
Paris, 75012
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
Official title: Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts
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.
Read more
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.
Read the 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.
- Being tested
- Data collection from hospital medical records
- Keywords
- Diaphyseal reconstruction techniques, Induced membrane technique, Vascularized fibula, Vascularized fibula grafts, Malignant tumors, Childhood
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from hospital medical recordsOther
Data collection from hospital medical records of patients concerning the 5 years following the resection of the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 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. Receives: Other: Data collection from hospital medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of bone consolidation period
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.
Measured: 5 years
Secondary outcomes (4)
Rate of surgical re-intervention
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.
Measured: 5 years
Short- and long-term complication rates
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.
Measured: 5 years
Long-term functional results
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.
Measured: 5 years
Relationship between radiotherapy and biological reconstruction result
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start30 May 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood Malignant Tumors of Lower LimbsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Edouard Haumont, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisEric Mascard, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361290
- Sponsor's protocol ID
- APHP231703
- Acronym
- RDTM
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16919776Arndt 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.
PubMed 10423470Hameed 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.
PubMed 21675380Whelan 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.
PubMed 22015453Le 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.
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.
PubMed 21037355
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphyseal Reconstruction Techniques of Lower Limbs in Childhood Malignant Tumors - Induced Membrane Technique Versus Vascularized Fibula Grafts
- ClinicalTrials.gov ID
- NCT06361290
- Acronym / sponsor ID
- RDTM / APHP231703
- Keywords
- Diaphyseal reconstruction techniques, Induced membrane technique, Vascularized fibula, Vascularized fibula grafts, Malignant tumors, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Data collection from hospital medical recordsPatients 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection from hospital medical recordsData collection from hospital medical records of patients concerning the 5 years following the resection of the tumor. | Other | Patients |
Primary outcome
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.
4 secondary outcomes
Rate of surgical re-intervention
Time frame: 5 years
Short- and long-term complication rates
Time frame: 5 years
Long-term functional results
Time frame: 5 years
Relationship between radiotherapy and biological reconstruction result
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 16919776Stiller 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.
- Background: PubMed 10423470Arndt 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.
- Background: PubMed 21675380Hameed 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.
- Background: PubMed 22015453Whelan 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.
- 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.
- Background: PubMed 21037355Hariri 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Haumont, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Eric Mascard, MD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Malignant Tumors of Lower Limbs, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of bone consolidation period (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361290, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.