Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient

Completed

• Conditions: Pediatric; Lower Limb Injury; Outcome; Osteosarcoma
• Interventions: Other: Retrospective analysis

• Registration Number: NCT06162962
• Lead Sponsor: Changye Zou

Brief Summary

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

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 Timeline

• Study Start: 2000-01-01
• Primary Completion: 2023-11-23
• Study Completion: 2023-11-23
• Study First Submitted: 2023-11-29
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Changye Zou; 🇨🇳 Guangzhou, Guangdong, China