Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2024-10-31

Brief Summary

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In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM

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Detailed Description

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In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MM patient candidate to vertebroplasty

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age≥ 18 years;
* Diagnosis of multiple myeloma;
* Clinical indication and eligibility for vertebroplasty procedure;
* Performance Status (ECOG) 0-2;
* Life expectancy greater than three months;
* Low-resolution full skeletal CT scan at disease onset and/or at follow-up;
* Spine pain with stiffness and functional impediment pre vertebroplasty;
* Able to express appropriate consent for participation in the study (e.g. Able to understand Italian, patient with intact cognitive abilities)

Exclusion Criteria

* presence of spinal cord compressions;
* unstable spinal injuries, requiring an orthopaedic back brace;
* risk of spinal cord injury;
* body mass index BMI\>28 kg/m2.
* absence of signed informed consent form

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No