Biomechanical and Metabolic Assessment Pre and Post Verte... | NCT06255639

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

NCT06255639

Sponsor

Centro di Riferimento Oncologico - Aviano

Status

Unknown status

Last Update Posted

Feb 13, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Jan 19, 2024

First Submission Date that Met QC Criteria

Feb 2, 2024

First Posted Date

Feb 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2024

Last Update Posted Date

Feb 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
MM patient candidate to vertebroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To explore the impact of vertebroplasty on thermal parameters	Central and superficial temperature will be measured before and after vertebroplasty. Difference will be reported as intrapatient mean difference	2 months
To explore the impact of vertebroplasty on metabolic parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariagrazia Michieli, MD	Contact	0434 659 020		mmichieli@cro.it

Overall Officials

Name	Affiliation	Role
Mariagrazia Michieli, MD	Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Recruiting	Aviano	Pordenone	33081	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

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Browse Branches

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