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

Rehabilitation Clinical Trial

— FISIO-ONCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376539
• Other study ID #: CEAVEC: 111/2024/Oss/IOR
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Mattia Morri, PT
• Phone: +390516366694
• Email: mattia.morri[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasm
• Bone Neoplasms
• Rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of participants able to walk	Number of participant that are able to walk and aids used for walking	up to 1 week
Secondary	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
Secondary	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
Secondary	Muscle Strength	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)	at 3 months after surgery
Secondary	Muscle Strength-2	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)	at 6 months after surgery
Secondary	Number of day from surgery to first walking	The number of day that participants needs to recover ambulation after surgery	up to 1 week