Gait Pattern in Tumoral Patients With a Distal Femur Megaprosthesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Distal Femoral Musculoskeletal Tumors

Intervention / Treatment
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* Diagnostic Test: Gait analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short Stem (Compress)<br>Compress megaprosthesis | Diagnostic Test: Gait analysis<br>* 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.<br>|
| Long Stem (conventional)<br>Conventional long stem megaprosthesis | Diagnostic Test: Gait analysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait symmetry index measured in percentage (%) | Gait symmetry is defined as the perfect agreement of the external kinetics and kinematics of the left and right legs | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone remmant (%) | Bone remment respect a healthy femur in percentage (%) | 3 months | 
| Long discrepancy (mm) | Long discrepancy in milimeters (mm) between healthy and tumoral leg. Positive discrepancy (tumoral leg longer) or negative discrepancy (tumoral leg shorter). | 3 months | 
| Stem occupation in femur remmant (%) | Stem occupation in femur remmant | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumors. Megaprosthesis. Gait analysis.