- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06522165
Pediatric Oncological Orthopaedic Reconstruction
July 29, 2025 updated by: Costantino Errani
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BO
-
Bologna, BO, Italy, 40136
- IRCCS Itituto Ortopedico Rizzoli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male and female pediatric patients surgically treated with an oncological reconstruction from 1991 to 2023
Description
Inclusion Criteria:
- Diagnosis of bone sarcoma
- Patients with available clinical and imaging data
Exclusion Criteria:
- At least one inclusion criteria not met
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients
Male and female patients surgically treated with an oncological reconstructions at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
|
analysis and review of imaging and clinical data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
longevity of the reconstruction
Time Frame: at baseline (day 0)
|
-assess the longevity associated with pediatric oncologic reconstructions;
|
at baseline (day 0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complications
Time Frame: at baseline (day 0)
|
assess the complications associated with pediatric oncologic reconstructions;
|
at baseline (day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Aponte-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.
- Azoury 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
July 22, 2024
First Submitted That Met QC Criteria
July 22, 2024
First Posted (Actual)
July 26, 2024
Study Record Updates
Last Update Posted (Actual)
August 1, 2025
Last Update Submitted That Met QC Criteria
July 29, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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