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

NCT06282198 | Completed

• 1 other identifier: UCHCEU-13/02/24
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Distal Femoral Musculoskeletal Tumors

Keywords

Megaprosthesis; Musculoskeletal tumor; Distal femur; Lower limb; Functional mobility; Quality of life; Case-Control Study; Inertial Measurement Unit

Outcome Measures

Primary Outcomes (3)

• SF-36 questionnaire

  This instrument assesses health-related quality of life and comprises 36 items, organized into eight subscales: physical functioning (10 items), physical role functioning (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), emotional role functioning (3 items), and mental health (5 items). Each subscale is scored on a scale from 0 to 100, with higher scores indicating better health status in that domain. In addition to individual subscale scores, two aggregate summary scores are calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These summary scores are norm-based, with a mean of 50 and a standard deviation of 10, allowing comparison to population averages. Scores above 50 represent better-than-average health, while scores below 50 indicate lower-than-average health-related quality of life.

  3 months

• Timed Up and Go Test

  Participants are seated in a chair with their backs against the backrest and their hands resting on their thighs. Upon the verbal command "GO", they are instructed to stand, walk down a 3-meter pathway, turn around, and return to a seated position as quickly and safely as possible. The recorded parameters include total TUG time (s), rotation speed during the middle and final turns (°/s), and vertical acceleration during the sit-to-stand and stand-to-sit transitions (m/s²)

  3 months

• 6 -Minute Walk Test

  This test is conducted in a continuous 30-meter corridor, where participants are instructed to walk for 6 minutes at their own preferred pace. The primary parameter measured is total walking distance (m)

  3 months

Secondary Outcomes (3)

• Sagittal range of movement of the knee measured with a goniometer

  3 months

• Muscular strength

  3 months

• MSTS Score

  3 months

Study Arms (2)

Cases

Patients with Distal Femoral megaprosthesis

Control

Healthy subjects

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Spain

Location

Study Officials

• Juan F Lisón, PhD

  Cardenal Herrera University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Profesor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: October 29, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

ES (1)