Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.

Completed

• Conditions: Distal Femoral Musculoskeletal Tumors; Megaprosthesis

• Registration Number: NCT05202873
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study Start: 2018-02-08
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antero-posterior acceleration symmetry index	3 months	This metric serves as a quantifiable measure of the symmetry exhibited in movements along the antero-posterior axis, thereby illustrating the equilibrium and coordination inherent in the body's kinetic activities.
Gait Quality Index	3 months	The stance-swing phase ratio
Pelvic tilt range	3 months	Refers to the total angular movement of the pelvis in the sagittal plane during a specific activity, such as walking. It represents the difference between the maximum anterior tilt (forward rotation) and maximum posterior tilt (backward rotation) of the pelvis within a given cycle. Measured in degrees (°) to quantify the extent of pelvic rotation.
Pelvic obliquity range	3 months	Refers to the total angular movement of the pelvis in the coronal (frontal) plane during activities such as walking. It describes the difference between the maximum upward tilt (hip hike) and maximum downward tilt (hip drop) of one side of the pelvis relative to the opposite side. Measured in degrees (°) to quantify the range of motion.
Pelvic rotation range	3 months	Refers to the total angular movement of the pelvis in the transverse (horizontal) plane during activities such as walking. It represents the difference between the maximum forward rotation and maximum backward rotation of the pelvis around a vertical axis within a given cycle. Measured in degrees (°) to quantify the range of rotational motion.
Pelvic symmetry tilt index	3 months	Is a quantitative measure that evaluates the symmetry of pelvic tilt during movement. It assesses the degree of deviation in pelvic tilt between the left and right sides in the sagittal plane, providing insight into potential imbalances or asymmetries. Expressed as a percentage (%) to indicate the level of symmetry.
Pelvic symmetry obliquity index	3 months	Is a quantitative measure used to evaluate the symmetry of pelvic obliquity during movement. It quantifies the degree of deviation in upward or downward tilt of the pelvis on one side compared to the other in the coronal (frontal) plane, helping to identify potential imbalances or asymmetries. Expressed as a percentage (%) to represent the level of symmetry.
Pelvic symmetry rotation index	3 months	Is a quantitative measure used to assess the symmetry of pelvic rotation during movement, particularly in the transverse (horizontal) plane. It calculates the difference in rotational movement between the left and right sides of the pelvis, helping to identify any imbalances or asymmetries in pelvic motion during activities like walking.Expressed as a percentage (%) to indicate the level of symmetry.
Stance Phase	3 months	Refers to the portion of the gait cycle during which a foot is in contact with the ground. It begins with the initial contact (heel strike) and ends when the same foot leaves the ground (toe-off). The stance phase is a critical component of walking and running, contributing to balance, propulsion, and weight-bearing.; Measured as a percentage of the total gait cycle, 60% of the cycle in typical walking.
Swing Phase	3 months	Refers to the portion of the gait cycle during which a foot is not in contact with the ground. It begins when the foot lifts off the ground (toe-off) and ends when the same foot makes contact again (heel strike). The swing phase allows the leg to advance forward and position itself for the next step. Measured as a percentage of the total gait cycle, 40% of the cycle in normal walking.
First Double support phase	3 months	Refers to the portion of the gait cycle during walking when both feet are in contact with the ground simultaneously. It occurs at the beginning of the stance phase for one leg, immediately after heel strike, and ends when the opposite foot lifts off (toe-off). This phase contributes to stability during gait. Measured as a percentage of the total gait cycle.
Single Support Phase	3 months	Refers to the portion of the gait cycle during which only one foot is in contact with the ground bearing the entire body weight while the other foot is in the swing phase. It is essential for maintaining balance and forward progression during walking. Measured as a percentage of the total gait cycle.
Propulsion Index	3 months	This measures the subject's ability to propel the centre of mass forward during the single support stance phase.

Secondary Outcome Measures

Name	Time	Method
Bone remmant (%)	3 months	Bone remment respect a healthy femur in percentage (%)
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).

Trial Locations

Locations (1)

Universidad Ceu Cardenal Herrera; 🇪🇸 Valencia, Spain