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Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.

NCT ID: NCT05202873

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-08

Study Completion Date

2024-11-01

Brief Summary

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

Detailed Description

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Patients with distal femoral prostheses treated at La Fe Hospital in Valencia were evaluated and compared with healthy controls. A radiographic study was conducted in cases using telemetric imaging to assess the percentage of remaining bone and the long length limb discrepancy following surgical intervention. Additionally, a gait analysis was performed using the BTS device to obtain objective gait parameters. The gait assessment was conducted with a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which was placed at the S1 level to collect spatio-temporal gait data. The data were analyzed in relation to the values in healthy patients.

Conditions

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Distal Femoral Musculoskeletal Tumors Megaprosthesis

Keywords

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Gait Analysis Case-control study Megaprosthesis Orthopedic oncology Musculoskeletal tumour Distal femur Inertial Measurement Unit

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Patients with distal femoral megaprosthesis due to musculoskeletal tumor

Gait analysis

Intervention Type DIAGNOSTIC_TEST

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 Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction.

Control

Healthy subjects

Gait analysis

Intervention Type DIAGNOSTIC_TEST

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 Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction.

Interventions

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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 Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Megaprosthesis of the distal femur
* Tumor cause
* Surgery at Hospital la Fe.
* Traditional stem or biological ossteointegration system
* Minimum postoperative follow-up period of 3 months

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
* Any ipsilateral or contralateral prosthesis.
* Infectious or traumatic cause
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Juan F. Lisón Párraga, Dr

Professor of the Deparment of Biomedical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JUAN FRANCISCO LISÓN, PhD

Role: STUDY_DIRECTOR

Cardenal Herrera University

Locations

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Universidad Ceu Cardenal Herrera

Valencia, , Spain

Site Status

Countries

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Spain

References

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Wilson PJ, Steadman P, Beckman EM, Connick MJ, Carty CP, Tweedy SM. Fitness, Function, and Exercise Training Responses after Limb Salvage With a Lower Limb Megaprosthesis: A Systematic Review. PM R. 2019 May;11(5):533-547. doi: 10.1002/pmrj.12045. Epub 2019 Mar 7.

Reference Type BACKGROUND
PMID: 30844129 (View on PubMed)

Morri M, Forni C, Ruisi R, Giamboi T, Giacomella F, Donati DM, Benedetti MG. Postoperative function recovery in patients with endoprosthetic knee replacement for bone tumour: an observational study. BMC Musculoskelet Disord. 2018 Oct 2;19(1):353. doi: 10.1186/s12891-018-2280-7.

Reference Type BACKGROUND
PMID: 30285683 (View on PubMed)

Other Identifiers

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UNIVERSITY CARDENAL HERRERA-62

Identifier Type: -

Identifier Source: org_study_id