Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis (MP-GP)

February 5, 2024 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis: Comparative Analysis of Conventional Stem vs Compress® Type Biological Osseointegration System

The main objective of the study is to evaluate motor function and spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to evaluate motor function and spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur. The type of prosthesis (Short Stem Compress® or Conventional long stem), the level of bone resection, the occupation of the stem in the bone remnant and long discrepancy are related to the functional capacity of the patients.

Our hypothesis is that short-stem prostheses and less bone resection have a better functional result than long-stem prostheses and long bone resection. In addition, we want to assess the relationship between the objective analysis of movement and the assessment using the most commonly used functional scales. Anamnesis and a complete clinical examination will be carried out in tumoral patients with megaprosthesis of the distal femur undergoing surgery at Hospital la Fe in Valencia, with assessment of joint mobility, strength of the different muscle groups and tendon reflexes in both lower limbs. By evaluating the complementary tests, lower limb telemetry, a study of long discrepancy will be carried out, the percentage of bone resection carried out with respect to the healthy femur, percentage of bone remnant and occupation of the stem with respect to the bone remnant. To assess the subjective function, we will use different questionnaires such as the SF36 and MSTS (Musculoskeletal Tumor Society Score). The assessment of the gait will be carried out using a non-invasive portable device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which is placed at the S1 level, and collects the spatio-temporal data of the gait. The data are analyzed with respect to the values in healthy patients.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46006
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent a megaprosthesis of the lower limb (distal femur) at Hospital La Fe by the orthopedic surgery and traumatology service, due to a tumor cause

Description

Inclusion Criteria:

  • Megaprosthesis of the distal femur
  • Tumor cause

Exclusion Criteria:

  • Neurological alterations prior to the intervention that affect the lower limbs or general movement.
  • Patient incapable of ambulation due to progression of his/her pathology
  • Patient at home with palliative treatment for advanced tumor disease
  • Proximal or complete femur megaprosthesis
  • Infectious, traumatic cause or sequel to revision surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Short Stem (Compress)
Compress megaprosthesis
Diagnostic test: Gait analysis
Gait assessment will be performed using a non-invasive device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy). The spatiotemporal variables of gait will be studied from the 6 'gait test, mobility, dynamic balance, gait ability and risk of falling through the Up and Go test.
Long Stem (conventional)
Conventional long stem megaprosthesis
Diagnostic test: Gait analysis
Gait assessment will be performed using a non-invasive device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy). The spatiotemporal variables of gait will be studied from the 6 'gait test, mobility, dynamic balance, gait ability and risk of falling through the Up and Go test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait symmetry index measured in percentage (%)
Time Frame: 3 months
Gait symmetry is defined as the perfect agreement of the external kinetics and kinematics of the left and right legs
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone remmant (%)
Time Frame: 3 months
Bone remment respect a healthy femur in percentage (%)
3 months
Long discrepancy (mm)
Time Frame: 3 months
Long discrepancy in milimeters (mm) between healthy and tumoral leg. Positive discrepancy (tumoral leg longer) or negative discrepancy (tumoral leg shorter).
3 months
Stem occupation in femur remmant (%)
Time Frame: 3 months
Stem occupation in femur remmant
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Study Director: JUAN FRANCISCO LISÓN, PhD, Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UNIVERSITY CARDENAL HERRERA-62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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