Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

Completed

• Conditions: Limb Salvage

• Registration Number: NCT02536053
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-31
• Study Start: 2015-12
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer center, Helsinki University Hospital and University of Helsinki; 🇫🇮 Helsinki, Helsinki And Uusimaa, Finland