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

Sponsor
Cardenal Herrera University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05202873
Collaborator
(none)
30
Enrollment
1
Location
59.8
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Gait analysis

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis: Comparative Analysis of Conventional Stem vs Compress® Type Biological Osseointegration System
Actual Study Start Date :
Feb 8, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Gait symmetry index measured in percentage (%) [3 months]

    Gait symmetry is defined as the perfect agreement of the external kinetics and kinematics of the left and right legs

Secondary Outcome Measures

  1. Bone remmant (%) [3 months]

    Bone remment respect a healthy femur in percentage (%)

  2. Long discrepancy (mm) [3 months]

    Long discrepancy in milimeters (mm) between healthy and tumoral leg. Positive discrepancy (tumoral leg longer) or negative discrepancy (tumoral leg shorter).

  3. Stem occupation in femur remmant (%) [3 months]

    Stem occupation in femur remmant

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Ceu Cardenal Herrera Valencia Spain 46006

Sponsors and Collaborators

  • Cardenal Herrera University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Juan F. Lisón Párraga, Dr, Professor of the Deparment of Biomedical Sciences, Cardenal Herrera University
ClinicalTrials.gov Identifier:
NCT05202873
Other Study ID Numbers:
  • UNIVERSITY CARDENAL HERRERA-62
First Posted:
Jan 24, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juan F. Lisón Párraga, Dr, Professor of the Deparment of Biomedical Sciences, Cardenal Herrera University
Tumors. Megaprosthesis. Gait analysis.

Study Results

No Results Posted as of Mar 10, 2022