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Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures (CaPvsPMMA)

Primary Purpose

SPINAL Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kyphos FS™ Bone Substitute
KYPHON ActivOs® Bone Cement with Hydroxyapatite
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SPINAL Fracture focused on measuring Spinal Fractures, Fractures, Polymethyl Methacrylate, PMMA, Bone Cements, Calciumphosphate, Thoracolumbar Fractures, Dorsal Instrumentation, Burst Fractures, Balloon Kyphoplasty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written consent of the participant after being informed
  • Acute trauma (surgery within three weeks following trauma)
  • Thoracolumbar fractures including segments TH 6-L5
  • A3/A4 fractures according to the AO Spine fracture classification
  • Patient age ≥ 50 years
  • Minimum follow up 1 year

Exclusion Criteria:

  • Presence of neurological deficits at the time of surgery
  • Pathological fractures (bone metastases)
  • Traumatic brain injury
  • Ankylosing spondylitis as a comorbidity
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    KYPHON® ActivOs™10 Bone Cement with hydroxyapatite

    KyphOs FS™

    Arm Description

    As a reference device KYPHON® ActivOs™10 Bone Cement with hydroxyapatite (Medtronic) for treatment of vertebral compression fractures will be used. It is a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. This bone substitute has already been approved and is in use in the patients at the age of 50 or older.

    The test device KyphOs FS™ will be used in patients at the age of 50 and older in order to prove its superiority over the currently used PMMA bone cement.

    Outcomes

    Primary Outcome Measures

    The change in correction rates when using CaP
    The main outcome measure 1 will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury.
    The change in correction rates when using PMMA
    The main outcome 2 measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury. Measurements will be taken from CT scans.

    Secondary Outcome Measures

    The change in vertebral body height when using CaP
    The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%. Measurements will be taken from CT scans.
    The change in vertebral body height when using PMMA
    The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%.
    Changes in complication rates when using PMMA
    The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
    Changes in complication rates when using CaP
    The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
    Change in the disability on the ODI rating scale in patients with PMMA
    ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
    Change in the disability on the ODI rating scale in patients with CaP
    ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
    Change in pain on the spine VAS in patients with PMMA
    VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
    Change in pain on the spine VAS in patients with CaP
    VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
    Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey
    The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
    Change in quality of life in patients with CaP measured by the 36-item Short Form Survey
    The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.

    Full Information

    First Posted
    February 3, 2021
    Last Updated
    February 3, 2021
    Sponsor
    Medical University of Graz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04743869
    Brief Title
    Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures
    Acronym
    CaPvsPMMA
    Official Title
    Calcium Phosphate Versus PMMA Cement in Unstable Thoracolumbar Burst Fractures Treated With Dorsal Instrumentation in Patients > 50 Years of Age Randomized Controlled Non-inferiority Trial Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients at the age of 50 or older presenting with thoracolumbar fractures including segments TH 6-L5 and A3/A4 fractures according to the AO Spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either Calciumphosphate (CaP) or Polymethylmethacrylate (PMMA) as part of a standardized treatment approach. Regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. The study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. At each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. The main outcome measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SPINAL Fracture
    Keywords
    Spinal Fractures, Fractures, Polymethyl Methacrylate, PMMA, Bone Cements, Calciumphosphate, Thoracolumbar Fractures, Dorsal Instrumentation, Burst Fractures, Balloon Kyphoplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Patients and study nurse will be blinded to treatment allocation; however, surgeons cannot be blinded due to different techniques of bone cement application. A centralized and automated internet-based randomization system will ensure concealed randomization of study participants. Participants will be the unit of randomization. Randomization will be carried out with randomizer.at and will occur prior to the surgical procedure.
    Allocation
    Randomized
    Enrollment
    85 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KYPHON® ActivOs™10 Bone Cement with hydroxyapatite
    Arm Type
    Active Comparator
    Arm Description
    As a reference device KYPHON® ActivOs™10 Bone Cement with hydroxyapatite (Medtronic) for treatment of vertebral compression fractures will be used. It is a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. This bone substitute has already been approved and is in use in the patients at the age of 50 or older.
    Arm Title
    KyphOs FS™
    Arm Type
    Experimental
    Arm Description
    The test device KyphOs FS™ will be used in patients at the age of 50 and older in order to prove its superiority over the currently used PMMA bone cement.
    Intervention Type
    Device
    Intervention Name(s)
    Kyphos FS™ Bone Substitute
    Other Intervention Name(s)
    KyphOs FS™ Bone Cement, KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USA
    Intervention Description
    Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KyphOs FS™ bone cement will be introduced in the fractured vertebral body.
    Intervention Type
    Device
    Intervention Name(s)
    KYPHON ActivOs® Bone Cement with Hydroxyapatite
    Other Intervention Name(s)
    KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USA
    Intervention Description
    Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KYPHON ActivOs® Bone Cement with Hydroxyapatite will be introduced in the fractured vertebral body.
    Primary Outcome Measure Information:
    Title
    The change in correction rates when using CaP
    Description
    The main outcome measure 1 will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury.
    Time Frame
    Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
    Title
    The change in correction rates when using PMMA
    Description
    The main outcome 2 measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury. Measurements will be taken from CT scans.
    Time Frame
    Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
    Secondary Outcome Measure Information:
    Title
    The change in vertebral body height when using CaP
    Description
    The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%. Measurements will be taken from CT scans.
    Time Frame
    Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
    Title
    The change in vertebral body height when using PMMA
    Description
    The percentage loss of the vertebral body height will be calculated by dividing the height of the fractured vertebra by the average height of the cephalad and caudad vertebrae and then subtracting this number from 100%.
    Time Frame
    Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
    Title
    Changes in complication rates when using PMMA
    Description
    The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
    Time Frame
    6 weeks, 3 months, 6 months and 12 months postoperatively
    Title
    Changes in complication rates when using CaP
    Description
    The occurence of the complication rates, in particular cement extravasation and temporary fall in blood pressure, will be compared between the two groups for each time point using the Student´s t-test for independent samples. In addition, a paired Student´s t-test will be performed within each group in order to evaluate the differences in means of the secondary endpoints measured at the defined timepoints.
    Time Frame
    6 weeks, 3 months, 6 months and 12 months postoperatively
    Title
    Change in the disability on the ODI rating scale in patients with PMMA
    Description
    ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
    Title
    Change in the disability on the ODI rating scale in patients with CaP
    Description
    ODI is mainly used in spine trauma patients. A score of 0% to 20% indicates minimal disability; 21% to 40%, moderate disability; and 41% to 60% severe disability.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
    Title
    Change in pain on the spine VAS in patients with PMMA
    Description
    VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
    Title
    Change in pain on the spine VAS in patients with CaP
    Description
    VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
    Title
    Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey
    Description
    The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
    Title
    Change in quality of life in patients with CaP measured by the 36-item Short Form Survey
    Description
    The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
    Time Frame
    Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written consent of the participant after being informed Acute trauma (surgery within three weeks following trauma) Thoracolumbar fractures including segments TH 6-L5 A3/A4 fractures according to the AO Spine fracture classification Patient age ≥ 50 years Minimum follow up 1 year Exclusion Criteria: Presence of neurological deficits at the time of surgery Pathological fractures (bone metastases) Traumatic brain injury Ankylosing spondylitis as a comorbidity Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gloria Hohenberger, Assist.Prof.
    Phone
    +43 316 385 81721
    Email
    gloria.hohenberger@medunigraz.at
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marina Bergovec, Dr. Sc.
    Phone
    +43 316 385 87436
    Email
    marina.bergovec@medunigraz.at
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Puchwein, Assist.Prof.
    Organizational Affiliation
    University Hospital Graz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Results of the study are planned to be made public within a scientific work.

    Learn more about this trial

    Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures

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