Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses (FOQ-DFP)

Cardenal Herrera University

Status: Completed

Conditions: Distal Femoral Musculoskeletal Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT06282198

UCHCEU-13/02/24

Details and patient eligibility

About

This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.

Full description

The aim of this case-control study will be to compare functional outcomes-including results from the TUG and 6MWT, knee flexor and extensor muscle strength, sagittal knee range of motion-and health-related quality of life between patients with distal femoral megaprostheses and healthy controls. By employing both traditional assessments and IMU technology, the investigators will provide a comprehensive evaluation of functional recovery in this population, thereby informing clinical practice and rehabilitation strategies.

Two functional tests that will be conducted are the Time Up and Go Test and the 6-Minute Walk Test. These tests will be administered using a non-invasive Inertial Measurement Unit (IMU), specifically the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), positioned at the S1 level to collect spatiotemporal gait data. These data will then be analyzed in comparison to values obtained from healthy participants.

The assessment will include anamnesis and a complete clinical examination of tumor patients with distal femur megaprostheses undergoing surgery at Hospital la Fe in Valencia, focusing on knee joint mobility and muscle group strength. Subjective function will be evaluated using questionnaires such as the SF-36 for both cases and controls and the MSTS (Musculoskeletal Tumor Society Score) for cases.

Enrollment: 79 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (cases group):

• Megaprosthesis of unilateral distal femur
• Tumor cause
• Ambulation capacity

Exclusion Criteria (cases group):

• Neurological alterations prior to the inervention than affect the lower limbs or general movement
• Patient incapable of ambulation due to progression of his/her pathology
• Patient with palliative treatment for advanced tumor diseas
• More than one ipsilateral or contralateral prosthesis
• Infection, traumatic or sequel to revision surgery cause

Trial design

79 participants in 2 patient groups

Cases

Description:

Patients with Distal Femoral megaprosthesis

Control

Description:

Healthy subjects