NCT06522165

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2023Jun 2026

Study Start

First participant enrolled

December 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 22, 2024

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • longevity of the reconstruction

    -assess the longevity associated with pediatric oncologic reconstructions;

    at baseline (day 0)

Secondary Outcomes (1)

  • complications

    at baseline (day 0)

Study Arms (1)

patients

Male and female patients surgically treated with an oncological reconstructions at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023

Other: Analysis

Interventions

analysis and review of imaging and clinical data

patients

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male and female pediatric patients surgically treated with an oncological reconstruction from 1991 to 2023

You may qualify if:

  • Diagnosis of bone sarcoma
  • Patients with available clinical and imaging data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (3)

  • 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.

    PMID: 19797576BACKGROUND
  • 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.

    PMID: 23476115BACKGROUND
  • 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.

    PMID: 36729876BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

December 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations