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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


NCT number NCT05202873
Study type Observational
Source Cardenal Herrera University
Contact
Status Enrolling by invitation
Phase
Start date February 8, 2018
Completion date February 1, 2023