Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures (CaPvsPMMA)

February 3, 2021 updated by: Medical University of Graz

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: KYPHON® ActivOs™10 Bone Cement with hydroxyapatite
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.
Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite
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.
Other Names:
  • KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USA
Experimental: KyphOs FS™
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.
Device: Kyphos FS™ Bone Substitute
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.
Other Names:
  • KyphOs FS™ Bone Cement
  • KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in correction rates when using CaP
Time Frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
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.
Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
The change in correction rates when using PMMA
Time Frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
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.
Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change in vertebral body height when using CaP
Time Frame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
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.
Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
The change in vertebral body height when using PMMA
Time Frame: Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
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%.
Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
Changes in complication rates when using PMMA
Time Frame: 6 weeks, 3 months, 6 months and 12 months postoperatively
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.
6 weeks, 3 months, 6 months and 12 months postoperatively
Changes in complication rates when using CaP
Time Frame: 6 weeks, 3 months, 6 months and 12 months postoperatively
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.
6 weeks, 3 months, 6 months and 12 months postoperatively
Change in the disability on the ODI rating scale in patients with PMMA
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
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.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in the disability on the ODI rating scale in patients with CaP
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
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.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in pain on the spine VAS in patients with PMMA
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in pain on the spine VAS in patients with CaP
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
VAS - Spine Visual Analogue Scale is a measurement that measures pain intensity and it is completed by patients themselves.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Change in quality of life in patients with CaP measured by the 36-item Short Form Survey
Time Frame: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
The 36-Item Short Form Survey (SF-36) will be used to assess patient´s self-reported quality of life.
Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Puchwein, Assist.Prof., University Hospital Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results of the study are planned to be made public within a scientific work.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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