Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient

Department of Orthopedic Oncology, The First Affiliated Hospital of Sun Yat-sen University

Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.

Study Overview

• Status: Completed
• Conditions: Osteosarcoma; Pediatric; Lower Limb Injury; Outcome
• Intervention / Treatment: Other: Retrospective analysis

Detailed Description

Clinical and functional outcomes were compared based on age groups, surgical methods, type of prosthesis, and primary tumor location. Patients were divided into the Low-age group (≤10 years old) and the High-age group (>10 years old). Overall Survival rate (OS), Progression-Free Survival rate (PFS), and prosthesis survival rate were assessed using Kaplan-Meier curves, and non-parametric survival analysis (log-rank test) was used for comparison. The incidence of complications, local relapse rate (LRR), metastasis rate, final limb-salvage and amputation rate, and Musculoskeletal Tumor Society (MSTS) score of different independent groups were further evaluated using χ2 test or Fisher's exact test, and t-test was employed to evaluate the measurement data.

• Study Type: Observational
• Enrollment (Actual): 345

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 518010
      • Changye Zou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to our department between 2000 and 2019 was conducted.

Description

Inclusion Criteria:

1. Diagnosed lower limb osteosarcoma patients under the age of 14;
2. Performing tumor resection treatment in our hospital;
3. There is complete clinical registration data available.

Exclusion Criteria:

1. Not undergoing surgical treatment in our hospital;
2. Age older than 14 years old;
3. No available clinical registration data or lost follow-up patients;
4. Non lower limb osteosarcoma patients.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
age groups; The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.	Other: Retrospective analysis; Retrospective analysis
surgical methods; The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.	Other: Retrospective analysis; Retrospective analysis
type of prosthesis; The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.	Other: Retrospective analysis; Retrospective analysis
primary tumor location; The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.	Other: Retrospective analysis; Retrospective analysis
Enneking stage; The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.	Other: Retrospective analysis; Retrospective analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival rate (OS)	Oncological outcomes	2000-2019
Progression-Free Survival rate (PFS)	Oncological outcomes	2000-2019
Local recurrence rate(LRR)	Oncological outcomes	2000-2019
Metastasis rate	Oncological outcomes	2000-2019
Final limb-salvage and amputation rate	Oncological outcomes	2000-2019
Prosthesis survival rate	Functional outcomes	2000-2019
Musculoskeletal Tumor Society (MSTS) score	Functional outcomes	2000-2019
Complications	Functional outcomes	2000-2019

Collaborators and Investigators

• Sponsor: Changye Zou

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Wounds and Injuries; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma; Leg Injuries
• Other Study ID Numbers: Changye Zou

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.
• IPD Sharing Time Frame: SCI online. The datasets are available from the corresponding author on reasonable request.
• IPD Sharing Access Criteria: The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No