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Completed

NCT Number: NCT06376539

Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor.

The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.

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Key information

Conditions

Bone Neoplasm Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Rehabilitation

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

Retrospective observational study will be conducted. The evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. Different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones.
  • All participants undergone soft tissue resection surgery on the of the lower limb
  • All types of oncological diagnoses will be taken considered: osteosarcoma, Ewing and others.

Exclusion criteria

  • Participants who undergo at our Institute only the surgical treatment while continuing adjuvant treatment at other centres
  • Participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our Institute

Treatment and study plan

Primary outcomes

  1. Toronto Extremity Salvage Score (TESS)

    Time frame: at 3 months after surgery

    Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.

  2. Toronto Extremity Salvage Score (TESS)

    Time frame: at 6 months after surgery

    Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.

Secondary outcomes

  1. Range of motion (ROM)

    Time frame: at 3 months after surgery

    The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer

  2. Rang of motion - 2 (ROM)

    Time frame: at 6 months after surgery

    The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer

  3. Number of participants able to walk

    Time frame: up to 1 week

    Number of participant that are able to walk and aids used for walking

  4. Time Up and Go -2 (TUG)

    Time frame: at 3 months after surgery

    Time it takes a person to get up from a chair, walk three metres, turn around, return to the chair and sit down again is measured.

  5. Time Up and Go (TUG)

    Time frame: at 6 months after surgery

    Time it takes a person to get up from a chair, walk three metres, turn around, return to the chair and sit down again is measured.

  6. Muscle Strength

    Time frame: at 3 months after surgery

    Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)

  7. Muscle Strength-2

    Time frame: at 6 months after surgery

    Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)

  8. Number of day from surgery to first walking

    Time frame: up to 1 week

    The number of day that participants needs to recover ambulation after surgery

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Functional Recovery in the First Six Postoperative Months of Cancer Patients Undergoing Lower Limb Resection and Reconstruction. An Observational Study

Acronym: FISIO-ONCO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Feb 3, 2026

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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