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

NCT06255639 | Recruiting

• 1 other identifier: CRO-2020-35
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Difference in mean of kinematic data for walking before and after vertebroplasty

  Difference in mean of kinematic data for walking before and after vertebroplasty

  2 months

• difference in mean of movement range for affected joints before and after vertebroplasty

  difference in mean of movement range for affected joints before and after vertebroplasty

  2 months

• Difference in mean of energy expenditure before and after vertebroplasty

  Difference in mean of energy expenditure before and after vertebroplasty

  2 months

Secondary Outcomes (5)

• To explore the impact of vertebroplasty on thermal parameters

  2 months

• To explore the impact of vertebroplasty on metabolic parameters

  2 months

• To explore the impact of vertebroplasty on metabolic parameters

  2 months

• To explore the impact of vertebroplasty on metabolic parameters

  2 months

• To explore the impact of vertebroplasty on pain

  2 months

Study Arms (1)

MM patient candidate to vertebroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mariagrazia Michieli, MD

  Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariagrazia Michieli, MD

CONTACT

0434 659 020; mmichieli@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 13, 2024
• Study Start: October 15, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

IT (1)