Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

Overview

This study aims to: 1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to 2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

Full Title of Study: “Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 10, 2020

Detailed Description

The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps. Patient hospital records are retrospectively reviewed to chart the demographic and clinical data. The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.

Interventions

  • Procedure: Limb salvage

Clinical Trial Outcome Measures

Primary Measures

  • Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
    • Time Frame: two to five years
    • The validity is studied
  • Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
    • Time Frame: two to five years
    • The test-retest reliability is studied
  • Health-related quality of life after limb salvage
    • Time Frame: two to five years
    • Assessment of health-related quality of life
  • Assessment of the functional ability after limb salvage
    • Time Frame: two to five years
    • Assessment of functional ability

Secondary Measures

  • Quality of Life Questionnaire-Core 30
    • Time Frame: two to five years
    • Health-related quality of life assessment
  • The 15-dimensions health-related quality of life instrument
    • Time Frame: two to five years
    • Health-related quality of life assessment
  • The Musculoskeletal Tumor Society score lower extremity section
    • Time Frame: two to five years
    • Functional assessment of the reconstructed limb
  • The Toronto Extremity Salvage Score lower extremity section
    • Time Frame: two to five years
    • Functional assessment of the reconstructed limb

Participating in This Clinical Trial

Inclusion Criteria

  • Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot – No metastasis at the time of diagnosis – Undergone limb salvage surgery – A minimum of 1 year follow-up – Written consent – Age > 18 Exclusion Criteria:

  • Age <18 – No limb-salvage surgery due to sarcoma

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jussi Repo, MD – Helsinki University Central Hospital
  • Overall Official(s)
    • Erkki J Tukiainen, MD, PhD, Study Director, Helsinki University Hospital and University of Helsinki
    • Carl Blomqvist, MD, PhD, Study Director, Helsinki University Hospital and University of Helsinki

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