Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor. (FISIO-ONCO)

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Bone Neoplasm

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants with bone tumor diagnosis treated at the hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toronto Extremity Salvage Score (TESS)	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.	at 3 months after surgery
Toronto Extremity Salvage Score (TESS)	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.	at 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)	The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer	at 3 months after surgery
Rang of motion - 2 (ROM)	The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer	at 6 months after surgery
Number of participants able to walk	Number of participant that are able to walk and aids used for walking	up to 1 week
Time Up and Go -2 (TUG)	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.	at 3 months after surgery
Time Up and Go (TUG)	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.	at 6 months after surgery
Muscle Strength	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)	at 3 months after surgery
Muscle Strength-2	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)	at 6 months after surgery
Number of day from surgery to first walking	The number of day that participants needs to recover ambulation after surgery	up to 1 week

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Morri M, Venturini E, Abbruzzese A, Meneghini M, Raffa D, Berti L, Donati D. The functional recovery trajectory in patients undergoing lower limb salvage surgery for bone tumour: an observational study. Support Care Cancer. 2026 Jan 28;34(2):136. doi: 10.1007/s00520-026-10374-x.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: physiotherapy; functional recovery; bone tumor
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms
• Other Study ID Numbers: CEAVEC: 111/2024/Oss/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No