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

Centro di Riferimento Oncologico - Aviano

Status: Enrolling

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Other

Identifiers

NCT06255639

CRO-2020-35

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

MM patient candidate to vertebroplasty