Lumbar FractureNEOGELNCT03431519
Percutaneous Injection Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
An observational study of Lumbar Fracture and Thoracic Fracture, run by University Hospital of Patras.
Trial summary
The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. Read more about this study
- Who is it for?
- Ages 38 to 53 years, women only
- Conditions the study is for
- Lumbar Fracture, Thoracic Fracture
- What is being tested?
- VP
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Feb 2016
- Phase
- Observational
- 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 38 to 53 years
- Women only
- Adult
Study population: Adult female patients that had a single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture, without any serious concomitant injuries.
Who may be able to join
- One single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture
- No other serious concomitant injuries
Who cannot join
- Polytrauma
- Neurologic impairment
- Spinal deformity
- Known malignancy
- Previous fracture or surgery in the same or adjacent vertebrae
About this study
Official title: Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. The hypotheses tested in this study were as follows: 1) whether Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely resorbed and replaced by cancellous bone.
Read the detailed description
Introduction Polymethacrylate (PMMA) is commonly used in vertebroplasty and balloon kyphoplasty, but its use has been associated with complications. This study tests three hypotheses: 1) whether strontium hydroxyapatite (Sr-HA) is equivalent to PMMA for restoring thoracolumbar vertebral body fractures, 2) if incidence of PMMA leakage is similar to that of Sr-HA leakage, and 3) whether Sr-HAis resorbed and substituted by new vertebral bone.
Materials and Methods Two age- and sex-matched groups received short percutaneous pedicle screw fixation plus PEEK implant (Kiva, VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA) filled with either Sr-HA (Group A) or PMMA (Group B) after A2- and A3/AO-type thoracolumbar vertebral body fractures. Visual Analog Scale (VAS) score and imaging parameters, which included segmental kyphosis angle (SKA), vertebral body height ratios (VBHr), spinal canal encroachment (SCE), bone cement leakage, and Sr-HA resorption, were compared between the two groups.
- Conditions
- Lumbar Fracture, Thoracic Fracture
- Being tested
- VP
- Keywords
- Thoracolumbar fractures, PMMA, KIVA, PEEK
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPProcedure or surgery
Also called Vertebroplasty
Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation
| Study group | Role | What they receive |
|---|---|---|
| Group A | The subjects received VP with PEEK and Sr-HA Receives: Procedure: VP | |
| Group B | The subjects received VP with PEEK and PMMA Receives: Procedure: VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Units on VAS scale (0-10)
Measured: 33 months
Secondary outcomes (5)
Segmental kyphosis angle (SKA)
Angle degrees measured on Xrays
Measured: 33 months
Vertebral body height ratios (VBHr)
Percentage measured on Xrays
Measured: 33 months
Spinal canal encroachment (SCE)
Percentage measured on CT scans
Measured: 33 months
Cement leakage
Yes or no (Boolean value)
Measured: 33 months
Sr-HA resorption
Yes or no (Boolean value)
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startApr 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Responsible party
- Principal investigator, Vasileios Syrimpeis, University Hospital of Patras
- Investigators
- Vasileios Syrimpeis, MD, Principal investigator, General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431519
- Sponsor's protocol ID
- 2018NEOGEL
- Acronym
- NEOGEL
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only data published in Scientific Journal Publication
Publications
Korovessis P, Mpountogianni E, Syrimpeis V, Baikousis A, Tsekouras V. Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate Plus Short-Segment Pedicle Screw Fixation for Traumatic A2- and A3/AO-Type Fractures in Adults. Adv Orthop. 2018 Mar 5;2018:6365472. doi: 10.1155/2018/6365472. eCollection 2018.
PubMed 29692935
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
- ClinicalTrials.gov ID
- NCT03431519
- Acronym / sponsor ID
- NEOGEL / 2018NEOGEL
- Conditions
- Lumbar Fracture, Thoracic Fracture
- Keywords
- Thoracolumbar fractures, PMMA, KIVA, PEEK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Study start
- Apr 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Feb 2018 (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.
The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. The hypotheses tested in this study were as follows: 1) whether Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely resorbed and replaced by cancellous bone.
Detailed description
Introduction Polymethacrylate (PMMA) is commonly used in vertebroplasty and balloon kyphoplasty, but its use has been associated with complications. This study tests three hypotheses: 1) whether strontium hydroxyapatite (Sr-HA) is equivalent to PMMA for restoring thoracolumbar vertebral body fractures, 2) if incidence of PMMA leakage is similar to that of Sr-HA leakage, and 3) whether Sr-HAis resorbed and substituted by new vertebral bone.
Materials and Methods Two age- and sex-matched groups received short percutaneous pedicle screw fixation plus PEEK implant (Kiva, VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA) filled with either Sr-HA (Group A) or PMMA (Group B) after A2- and A3/AO-type thoracolumbar vertebral body fractures. Visual Analog Scale (VAS) score and imaging parameters, which included segmental kyphosis angle (SKA), vertebral body height ratios (VBHr), spinal canal encroachment (SCE), bone cement leakage, and Sr-HA resorption, were compared between the two groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: VPThe subjects received VP with PEEK and Sr-HA |
| Group B | – | Procedure: VPThe subjects received VP with PEEK and PMMA |
Who may qualify
- Ages
- 38 to 53 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Adult female patients that had a single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture, without any serious concomitant injuries.
Key inclusion criteria (2 listed)
- One single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture
- No other serious concomitant injuries
Key exclusion criteria (5 listed)
- Polytrauma
- Neurologic impairment
- Spinal deformity
- Known malignancy
- Previous fracture or surgery in the same or adjacent vertebrae
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 |
|---|---|---|
| VPAlso: VertebroplastyPercutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation | Procedure or surgery | Group A, Group B |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 33 months
Units on VAS scale (0-10)
5 secondary outcomes
Segmental kyphosis angle (SKA)
Time frame: 33 months
Vertebral body height ratios (VBHr)
Time frame: 33 months
Spinal canal encroachment (SCE)
Time frame: 33 months
Cement leakage
Time frame: 33 months
Sr-HA resorption
Time frame: 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 29692935Korovessis P, Mpountogianni E, Syrimpeis V, Baikousis A, Tsekouras V. Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate Plus Short-Segment Pedicle Screw Fixation for Traumatic A2- and A3/AO-Type Fractures in Adults. Adv Orthop. 2018 Mar 5;2018:6365472. doi: 10.1155/2018/6365472. eCollection 2018.
- Individual participant dataSharing planned: No. Only data published in Scientific Journal Publication
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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.
Vasileios Syrimpeis, MD principal investigator
General Hospital of Patras
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Fracture and Thoracic Fracture, run by University Hospital of Patras.
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 2 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: finished, as of the sponsor's last update on 13 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431519, which also lists 1 linked publication.
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 13 Feb 2018.