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Trial Title:
Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
NCT ID:
NCT06255639
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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
Detailed 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
Criteria for eligibility:
Study pop:
Patients suffering from multiple myeloma (MM) with multiple vertebral lesions and
candidates for vertebroplasty, consecutively diagnosed with MM in the period from 2015 to
2021 at the study center
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Ageā„ 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mariagrazia Michieli, MD
Phone:
0434 659 020
Email:
mmichieli@cro.it
Investigator:
Last name:
Mariagrazie Michieli, MD
Email:
Principal Investigator
Start date:
October 15, 2020
Completion date:
October 2024
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255639
