Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures (CaPvsPMMA)

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: Not yet recruiting
• Conditions: SPINAL Fracture
• Intervention / Treatment: Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite; Device: Kyphos FS™ Bone Substitute

• Study Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gloria Hohenberger, Assist.Prof.; Phone Number: +43 316 385 81721; Email: gloria.hohenberger@medunigraz.at
• Study Contact Backup: Name: Marina Bergovec, Dr. Sc.; Phone Number: +43 316 385 87436; Email: marina.bergovec@medunigraz.at

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
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.	Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
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%.	Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively
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.	6 weeks, 3 months, 6 months and 12 months postoperatively
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.	6 weeks, 3 months, 6 months and 12 months postoperatively
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.	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	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	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	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	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	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

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Paul Puchwein, Assist.Prof., University Hospital Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Fractures; Balloon Kyphoplasty; PMMA; Spinal Fractures; Polymethyl Methacrylate; Bone Cements; Calciumphosphate; Thoracolumbar Fractures; Dorsal Instrumentation; Burst Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID 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