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

Recruiting

• Conditions: Rehabilitation; Bone Neoplasm

• Registration Number: NCT06376539
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

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 Timeline

• Study Start: 2024-04-10
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toronto Extremity Salvage Score (TESS)	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 Outcome Measures

Name	Time	Method
Number of participants able to walk	up to 1 week	Number of participant that are able to walk and aids used for walking
Range of motion (ROM)	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
Muscle Strength-2	at 6 months after surgery	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)
Rang of motion - 2 (ROM)	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
Time Up and Go (TUG)	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.
Time Up and Go -2 (TUG)	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.
Muscle Strength	at 3 months after surgery	Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)
Number of day from surgery to first walking	up to 1 week	The number of day that participants needs to recover ambulation after surgery

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy