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Completed

NCT Number: NCT02536053

Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

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.

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Key information

Conditions

Limb Salvage

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer center, Helsinki University Hospital and University of Helsinki

Helsinki, Helsinki and Uusimaa, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Limb salvage

Procedure

Primary outcomes

  1. 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

  2. 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

  3. Health-related quality of life after limb salvage

    Time frame: two to five years

    Assessment of health-related quality of life

  4. Assessment of the functional ability after limb salvage

    Time frame: two to five years

    Assessment of functional ability

Secondary outcomes

  1. Quality of Life Questionnaire-Core 30

    Time frame: two to five years

    Health-related quality of life assessment

  2. The 15-dimensions health-related quality of life instrument

    Time frame: two to five years

    Health-related quality of life assessment

  3. The Musculoskeletal Tumor Society score lower extremity section

    Time frame: two to five years

    Functional assessment of the reconstructed limb

  4. The Toronto Extremity Salvage Score lower extremity section

    Time frame: two to five years

    Functional assessment of the reconstructed limb

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2015
Registry last updated
Jan 19, 2021

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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