Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06162962
• Other study ID #: Changye Zou
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: November 23, 2023

Study information

• Verified date: December 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Injuries
• Lower Limb Injury
• Osteosarcoma
• Outcome
• Pediatric

Intervention

Other:
• Retrospective analysis
Retrospective analysis

Locations

Country	Name	City	State
China	Changye Zou	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Changye Zou

Country where clinical trial is conducted

China, 

Outcome

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