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

NCT06376539 | Completed

• 1 other identifier: CEAVEC: 111/2024/Oss/IOR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rehabilitation; Bone Neoplasm

Keywords

bone tumor; physiotherapy; functional recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Range of motion (ROM)

  at 3 months after surgery

• Rang of motion - 2 (ROM)

  at 6 months after surgery

• Number of participants able to walk

  up to 1 week

• Time Up and Go -2 (TUG)

  at 3 months after surgery

• Time Up and Go (TUG)

  at 6 months after surgery

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants with bone tumor diagnosis treated at the hospital

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

• 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.

  PMID: 41593389 DERIVED

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 19, 2024
• Study Start: April 10, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)