SPINAL FractureCaPvsPMMANCT04743869
Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures
A study testing Kyphos FS™ Bone Substitute and KYPHON ActivOs® Bone Cement with Hydroxyapatite in people with SPINAL Fracture, run by Medical University of Graz.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- SPINAL Fracture
- What is being tested?
- Kyphos FS™ Bone Substitute and KYPHON ActivOs® Bone Cement with Hydroxyapatite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of neurological deficits at the time of surgery
- Pathological fractures (bone metastases)
- Traumatic brain injury
- Ankylosing spondylitis as a comorbidity
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- SPINAL Fracture
- Being tested
- Kyphos FS™ Bone Substitute, KYPHON ActivOs® Bone Cement with Hydroxyapatite
- Keywords
- Spinal Fractures, Fractures, Polymethyl Methacrylate, PMMA, Bone Cements, Calciumphosphate, Thoracolumbar Fractures, Dorsal Instrumentation, Burst Fractures, Balloon Kyphoplasty
- Medical subject headings
- Spinal Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphos FS™ Bone SubstituteDevice
Also called KyphOs FS™ Bone Cement, KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USA
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.
KYPHON ActivOs® Bone Cement with HydroxyapatiteDevice
Also called KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USA
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.
| Study group | Role | What they receive |
|---|---|---|
| KYPHON® ActivOs™10 Bone Cement with hydroxyapatite | Active comparator | 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. Receives: Device: KYPHON ActivOs® Bone Cement with Hydroxyapatite |
| KyphOs FS™ | Experimental | 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. Receives: Device: Kyphos FS™ Bone Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
Secondary outcomes (10)
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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Puchwein, Assist.Prof., Principal investigator, Universitäts-Frauenklinik Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743869
- Sponsor's protocol ID
- V 2.0
- Acronym
- CaPvsPMMA
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study are planned to be made public within a scientific work.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04743869
- Acronym / sponsor ID
- CaPvsPMMA / V 2.0
- Conditions
- SPINAL Fracture
- Keywords
- Spinal Fractures, Fractures, Polymethyl Methacrylate, PMMA, Bone Cements, Calciumphosphate, Thoracolumbar Fractures, Dorsal Instrumentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KYPHON® ActivOs™10 Bone Cement with hydroxyapatite | Active comparator | Device: KYPHON ActivOs® Bone Cement with HydroxyapatiteAs 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. |
| KyphOs FS™ | Experimental | Device: Kyphos FS™ Bone SubstituteThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Presence of neurological deficits at the time of surgery
- Pathological fractures (bone metastases)
- Traumatic brain injury
- Ankylosing spondylitis as a comorbidity
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kyphos FS™ Bone SubstituteAlso: KyphOs FS™ Bone Cement, KyphOs FS™ Medtronic Spine LLC, Minneapolis, MN, USADorsal 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. | Device | KyphOs FS™ |
| KYPHON ActivOs® Bone Cement with HydroxyapatiteAlso: KYPHON ActivOs® Bone Cement with Hydroxyapatite, Medtronic Spine LLC, Minneapolis, MN, USADorsal 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. | Device | KYPHON® ActivOs™10 Bone Cement with hydroxyapatite |
Primary outcome
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.
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.
10 secondary outcomes
The change in vertebral body height when using CaP
Time frame: 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
Changes in complication rates when using PMMA
Time frame: 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
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No. Results of the study are planned to be made public within a scientific work.
Related trials for SPINAL Fracture
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Puchwein, Assist.Prof. principal investigator
Universitäts-Frauenklinik Graz
Questions about this trial
What is this clinical trial studying?
A study testing Kyphos FS™ Bone Substitute and KYPHON ActivOs® Bone Cement with Hydroxyapatite in people with SPINAL Fracture, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Hohenberger, Assist.Prof. (+43 316 385 81721, gloria.hohenberger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in correction rates when using CaP (time frame: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.