Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses

NCT ID: NCT06282198

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2024-10-29

Brief Summary

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

Detailed 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.

Conditions

Distal Femoral Musculoskeletal Tumors

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cases

Patients with Distal Femoral megaprosthesis

No interventions assigned to this group

Control

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Chair Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan F Lisón, PhD

Role: STUDY_DIRECTOR

Cardenal Herrera University

Locations

Universidad CEU Cardenal Herrera

Valencia, , Spain

Countries

Spain

Other Identifiers

UCHCEU-13/02/24

Identifier Type: -

Identifier Source: org_study_id