Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

Limb Salvage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536053
• Other study ID #: 324/13/03/02/2014/2
• Status: Completed
• Start date: December 2015
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 15, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Limb Salvage
• Sarcoma

Intervention

Procedure:
• Limb salvage

Locations

Country	Name	City	State
Finland	Cancer center, Helsinki University Hospital and University of Helsinki	Helsinki	Helsinki And Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score	The validity is studied	two to five years
Primary	Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score	The test-retest reliability is studied	two to five years
Primary	Health-related quality of life after limb salvage	Assessment of health-related quality of life	two to five years
Primary	Assessment of the functional ability after limb salvage	Assessment of functional ability	two to five years
Secondary	Quality of Life Questionnaire-Core 30	Health-related quality of life assessment	two to five years
Secondary	The 15-dimensions health-related quality of life instrument	Health-related quality of life assessment	two to five years
Secondary	The Musculoskeletal Tumor Society score lower extremity section	Functional assessment of the reconstructed limb	two to five years
Secondary	The Toronto Extremity Salvage Score lower extremity section	Functional assessment of the reconstructed limb	two to five years