Clinical trial NCT06282198: Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses
Official title: Evaluating Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Femoral Musculoskeletal Tumors
Keywords: Megaprosthesis
Musculoskeletal tumor
Distal femur
Lower limb
Functional mobility
Quality of life
Case-Control Study
Inertial Measurement Unit
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 79
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: Patients with megaprosthesis of the distal femur due to tumor treated at Hospital Universitario la Fe.

Controls: Healthy volunteers

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.

Eligibility 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

Primary outcomes:
measure: SF-36 questionnaire
timeFrame: 3 months
measure: Timed Up and Go Test
timeFrame: 3 months
measure: 6 -Minute Walk Test
timeFrame: 3 months
Secondary outcomes:
measure: Sagittal range of movement of the knee measured with a goniometer
timeFrame: 3 months
measure: Muscular strength
timeFrame: 3 months
measure: MSTS Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad CEU Cardenal Herrera
Study officials:
affiliation: Cardenal Herrera University
name: Juan F Lisón, PhD
role: STUDY_DIRECTOR
References: