Bone TumorNCT06522165
Pediatric Oncological Orthopaedic Reconstruction
An observational study of Bone Tumor and Bone Cancer, run by Costantino Errani at 1 site in Italy.
Trial summary
From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Bone Tumor, Bone Cancer
- What is being tested?
- Analysis
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Male and female pediatric patients surgically treated with an oncological reconstruction from 1991 to 2023
Who may be able to join
- Diagnosis of bone sarcoma
- Patients with available clinical and imaging data
Who cannot join
- At least one inclusion criteria not met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Oncological Orthopaedic Reconstruction : "Analysis of the Clinical and Radiographic Results"
From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients
- Conditions
- Bone Tumor, Bone Cancer
- Being tested
- Analysis
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalysisOther
analysis and review of imaging and clinical data
| Study group | Role | What they receive |
|---|---|---|
| patients | Male and female patients surgically treated with an oncological reconstructions at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023 Receives: Other: Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
longevity of the reconstruction
-assess the longevity associated with pediatric oncologic reconstructions;
Measured: at baseline (day 0)
Secondary outcomes (1)
complications
assess the complications associated with pediatric oncologic reconstructions;
Measured: at baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Costantino Errani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522165
- Sponsor's protocol ID
- ROP
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdeen A, Hoang BH, Athanasian EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009 Oct;91(10):2406-15. doi: 10.2106/JBJS.H.00815.
PubMed 19797576Aponte-Tinao LA, Ayerza MA, Muscolo DL, Farfalli GL. Allograft reconstruction for the treatment of musculoskeletal tumors of the upper extremity. Sarcoma. 2013;2013:925413. doi: 10.1155/2013/925413. Epub 2013 Feb 14.
PubMed 23476115Azoury SC, Shammas RL, Othman S, Sergesketter A, Brigman BE, Nguyen JC, Arkader A, Weber KL, Erdmann D, Levin LS, Kovach SJ, Innocenti M. Outcomes following Free Fibula Physeal Transfer for Pediatric Proximal Humerus Reconstruction: An International Multi-Institutional Study. Plast Reconstr Surg. 2023 Apr 1;151(4):805-813. doi: 10.1097/PRS.0000000000010001. Epub 2022 Dec 6.
PubMed 36729876
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Oncological Orthopaedic Reconstruction : "Analysis of the Clinical and Radiographic Results"
- ClinicalTrials.gov ID
- NCT06522165
- Acronym / sponsor ID
- ROP
- Conditions
- Bone Tumor, Bone Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Costantino ErraniUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Jul 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.
From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: AnalysisMale and female patients surgically treated with an oncological reconstructions at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male and female pediatric patients surgically treated with an oncological reconstruction from 1991 to 2023
Key inclusion criteria (2 listed)
- Diagnosis of bone sarcoma
- Patients with available clinical and imaging data
Key exclusion criteria (1 listed)
- At least one inclusion criteria not met
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 |
|---|---|---|
| Analysisanalysis and review of imaging and clinical data | Other | patients |
Primary outcome
longevity of the reconstruction
Time frame: at baseline (day 0)
-assess the longevity associated with pediatric oncologic reconstructions;
1 secondary outcome
complications
Time frame: at baseline (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 19797576Abdeen A, Hoang BH, Athanasian EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009 Oct;91(10):2406-15. doi: 10.2106/JBJS.H.00815.
- Background: PubMed 23476115Aponte-Tinao LA, Ayerza MA, Muscolo DL, Farfalli GL. Allograft reconstruction for the treatment of musculoskeletal tumors of the upper extremity. Sarcoma. 2013;2013:925413. doi: 10.1155/2013/925413. Epub 2013 Feb 14.
- Background: PubMed 36729876Azoury SC, Shammas RL, Othman S, Sergesketter A, Brigman BE, Nguyen JC, Arkader A, Weber KL, Erdmann D, Levin LS, Kovach SJ, Innocenti M. Outcomes following Free Fibula Physeal Transfer for Pediatric Proximal Humerus Reconstruction: An International Multi-Institutional Study. Plast Reconstr Surg. 2023 Apr 1;151(4):805-813. doi: 10.1097/PRS.0000000000010001. Epub 2022 Dec 6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Tumor and Bone Cancer, run by Costantino Errani at 1 site in Italy.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
longevity of the reconstruction (time frame: at baseline (day 0)). 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 NCT06522165, which also lists 3 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 1 Aug 2025.