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Completed

NCT Number: NCT06162962

Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient

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

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Key information

Conditions

Osteosarcoma Leg Injuries Lower Limb Injury Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Outcome Pediatric Sarcoma Wounds and Injuries

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changye Zou

Guangzhou, Guangdong, 518010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

retrospective analysis

Other

Retrospective analysis

Primary outcomes

  1. Overall Survival rate (OS)

    Time frame: 2000-2019

    Oncological outcomes

  2. Progression-Free Survival rate (PFS)

    Time frame: 2000-2019

    Oncological outcomes

  3. Local recurrence rate(LRR)

    Time frame: 2000-2019

    Oncological outcomes

  4. Metastasis rate

    Time frame: 2000-2019

    Oncological outcomes

  5. Final limb-salvage and amputation rate

    Time frame: 2000-2019

    Oncological outcomes

  6. Prosthesis survival rate

    Time frame: 2000-2019

    Functional outcomes

  7. Musculoskeletal Tumor Society (MSTS) score

    Time frame: 2000-2019

    Functional outcomes

  8. Complications

    Time frame: 2000-2019

    Functional outcomes

Sponsors and collaborators

Lead sponsor

Changye Zou

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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