Clinical trial NCT05202873: Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.
Official title: Comparative Analysis of Spatiotemporal Gait Parameters in Patients With Distal Femoral Megaprosthesis and Healthy Subjects Using an Inertial Measurement Unit (IMU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Femoral Musculoskeletal Tumors
Megaprosthesis
Keywords: Gait Analysis
Case-control study
Megaprosthesis
Orthopedic oncology
Musculoskeletal tumour
Distal femur
Inertial Measurement Unit
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 79
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antero-posterior acceleration symmetry index
timeFrame: 3 months
measure: Stance Phase
timeFrame: 3 months
measure: Swing Phase
timeFrame: 3 months
measure: Gait Quality Index
timeFrame: 3 months
measure: First Double support phase
timeFrame: 3 months
measure: Single Support Phase
timeFrame: 3 months
measure: Propulsion Index
timeFrame: 3 months
measure: Pelvic tilt range
timeFrame: 3 months
measure: Pelvic obliquity range
timeFrame: 3 months
measure: Pelvic rotation range
timeFrame: 3 months
measure: Pelvic symmetry tilt index
timeFrame: 3 months
measure: Pelvic symmetry obliquity index
timeFrame: 3 months
measure: Pelvic symmetry rotation index
timeFrame: 3 months
Secondary outcomes:
measure: Bone remmant (%)
timeFrame: 3 months
measure: Long discrepancy (mm)
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad Ceu Cardenal Herrera
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO LISÓN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.