Patients with Distal Femoral megaprosthesis

Juan F Lisón, PhD

Nadia Jover, Medicine

JF Lisón, PhD

The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses.

This study aims to investigate the gait symmetry index in participants with distal femur tumor prostheses in comparison to a control group.

The hypothesis suggests that the symmetry index in participants will be lower than that of healthy controls. Additionally, the investigators aim to evaluate key spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals, assess the impact of lower limb megaprostheses on participants' quality of life and function, study residual dysmetria among participants with distal femur megaprostheses, compare differences in gait patterns based on the type of femoral fixation used, and establish a correlation between spatiotemporal gait data and participants' functional capacity as assessed through various questionnaires.

The assessment will include anamnesis and a complete clinical examination of tumoral participants with megaprostheses of the distal femur undergoing surgery at Hospital la Fe in Valencia, with a focus on joint mobility and muscle group strength. Subjective function will be evaluated using questionnaires such as the SF36 and MSTS (Musculoskeletal Tumor Society Score). Gait assessment will be conducted using a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), positioned at the S1 level to collect spatiotemporal gait data. These data will be analyzed in comparison to values obtained from healthy participants.

Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses

Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses Due to Tumor. Case-control Study.

Gait symmetry is defined as de perfect agreement of the external kinetics and kinematics of the left and right legs. This index allows to evaluate the patient's ability to have the same pattern of acceleration and deceleration of their center of mass, regardless of the side of the gait cycle

Sagittal range of movement of pathologic knee and healthy knee in controls.Full knee extension is considered 0º. The full range of knee mobility determined by the sum of the degrees of flexion plus the degrees of extension.

We measure muscle strength in the quadriceps and hamstrings of the pathological leg in the cases and one of the legs in the controls. For this we use the Medical Research Council Scale.

On this scale, contraction is assessed from 0-5.

Grade 5: Normal

Grade 4: Movement against gravity and resistance

Grade 3: Movement against gravity over (almost) the full range

Grade 2: Movement of the limb but not against gravity

Grade 1: Visible contraction without movement of the limb

Grade 0: No visible contraction

Cardenal Herrera University

Chair Profesor

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.

Gait analysis

JUAN FRANCISCO LISÓN, PhD

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 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.

Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis

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

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

Bone remment respect a healthy femur in percentage (%)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses	NCT06282198	Distal Femoral ...		16 Years - 99 Years	Cardenal Herrera University
Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis	NCT05202873	Distal Femoral ...	Gait analysis	16 Years - 99 Years	Cardenal Herrera University
Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses	NCT06282198	Distal Femoral ...		16 Years - 99 Years	Cardenal Herrera University

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