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

Evaluating Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses: A Case-Control Study

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

Study Overview

• Status: Completed
• Conditions: Distal Femoral Musculoskeletal Tumors

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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Universidad CEU Cardenal Herrera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy subjects
Cases; Patients with Distal Femoral megaprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sagittal range of movement of the knee measured with a goniometer	Sagittal range of movement of pathologic knee and healthy knee in controls.Full knee extension is considered 0º. The full range of knee mobility determined by the sum of the degrees of flexion plus the degrees of extension.	3 months
Muscular strength	We measure muscle strength in the quadriceps and hamstrings of the pathological leg in the cases and one of the legs in the controls. For this we use the Medical Research Council Scale. On this scale, contraction is assessed from 0-5. Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb Grade 0: No visible contraction	3 months
MSTS Score	Musculoskeletal Tumour Society (MSTS) Score evaluates patients' subjective functional capabilities. This assessment comprises six subscales: pain, function, emotional acceptance, use of assistive devices for ambulation, walking ability, and gait. Each subscale is rated on a scale from 0 to 5 points, with 5 indicating the most favorable outcome. Total scores are categorized as follows: poor (<15%), fair (15-17%), moderate (18-20%), good (21-22%), and excellent (23-30%). Higher total scores reflect better functional performance	3 months

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Study Director: Juan F Lisón, PhD, Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Functional mobility; Case-Control Study; Lower limb; Inertial Measurement Unit; Distal femur; Megaprosthesis; Musculoskeletal tumor
• Other Study ID Numbers: UCHCEU-13/02/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No