Vertebral Compression FractureNCT07507565
Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation.
A study testing Thermal facet ablation, Vertebroplasty and Kyphoplasty in people with Vertebral Compression Fracture, run by Szeged University at 1 site in Hungary.
Trial summary
Study design: A prospective randomized study is performed and cases are selected where the indication for surgery is a vertebral compression fracture. Object: To assess outcomes and complications in patients undergoing vertebroplasty, kyphoplasty and thermal facet ablation for vertebral compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fracture
- What is being tested?
- Thermal facet ablation, Vertebroplasty and Kyphoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteHungary
- Study dates
- 15 Dec 2020to 20 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years-old
- Subjects who are able to give informed consent and to understand and comply with study requirements.
- Predominantly axial back and low back pain ≥ 1 month in duration with no radicular pain below the knee that failed to conservative therapy.
- Subjects who have chronic back pain attributed to vertebral compression fractures (AO Spine A1 or A2 fractures) based on clinical evaluation (CT or MRI).
Who cannot join
- Subjects who decline to provide written consent or follow-up.
- Subjects who are pregnant.
- Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
- Subjects who have an active systemic or local infection.
- Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
- Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)
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- Psychopathology including depression, somatization or poor coping skills
- Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI > 35kg/m2).
- History of previous Radiofrequency Ablation at the same level(s) in the previous 12 months.
- History of previous Vertebroplasty at the same level(s) in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty, Stentoplasty and Kyphoplasty Versus Thermal Facet Ablation.
Study design: A prospective randomized study is performed and cases are selected where the indication for surgery is a vertebral compression fracture.
Object: To assess outcomes and complications in patients undergoing vertebroplasty, kyphoplasty and thermal facet ablation for vertebral compression.
- Conditions
- Vertebral Compression Fracture
- Being tested
- Thermal facet ablation, Vertebroplasty, Kyphoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal facet ablationProcedure or surgery
A minimally invasive procedure that uses heat radiofrequency) to target and disable the sensory nerves around damaged facet joints in the spine, stopping pain signals to the brain for relief from chronic back pain, stiffness, and limited mobility, with minimal scarring and quick recovery, often done with local anesthetic.
VertebroplastyProcedure or surgery
A minimally invasive procedure to treat painful spinal compression fractures, by injecting special bone cement (polymethyl methacrylate) into the fractured vertebra using a needle guided by imaging (fluoroscopy) for stabilization and pain relief.
KyphoplastyProcedure or surgery
A minimally invasive spine procedure to treat painful vertebral compression fractures by using a balloon to restore height to a collapsed vertebra, then filling the space with bone cement. The surgeon inserts a tube, inflates a balloon to create space and realign the bone, removes the balloon, and injects cement, all guided by real-time X-rays (fluoroscopy).
| Study group | Role | What they receive |
|---|---|---|
| thermal facet ablation | Active comparator | A minimally invasive procedure designed to alleviate chronic back pain originating from the facet joints using radiofrequency energy. This process, known as denervation, aims to provide long-term pain relief and improve physical function without affecting motor nerves. Receives: Procedure: Thermal facet ablation |
| Vertebroplasty | Active comparator | Minimally invasive image-guided procedure with percutaneous injection of bone cement into the fractured vertebral body. The cement hardens quickly, stabilizing the fracture, strengthening the vertebra, and providing rapid pain relief by preventing further micro-movements at the fracture site. Receives: Procedure: Vertebroplasty; Procedure: Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) Pain Score 2-day After Procedure, VAS Score Evaluation 0: No pain
1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain
Measured: 2 days after the treatment
Secondary outcomes (1)
Visual Analog Scale (VAS) 2 months
Visual Analog Scale (VAS) Pain Score 2-months After Procedure VAS Score Evaluation 0: No pain
1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain
Measured: 2 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Dec 2020
- Primary completion31 Jul 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamás Tóth, MD, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507565
- Sponsor's protocol ID
- 4868/2020
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty, Stentoplasty and Kyphoplasty Versus Thermal Facet Ablation.
- ClinicalTrials.gov ID
- NCT07507565
- Acronym / sponsor ID
- 4868/2020
- Conditions
- Vertebral Compression Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 2 Apr 2026 (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.
Study design: A prospective randomized study is performed and cases are selected where the indication for surgery is a vertebral compression fracture.
Object: To assess outcomes and complications in patients undergoing vertebroplasty, kyphoplasty and thermal facet ablation for vertebral compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thermal facet ablation | Active comparator | Procedure: Thermal facet ablationA minimally invasive procedure designed to alleviate chronic back pain originating from the facet joints using radiofrequency energy. This process, known as denervation, aims to provide long-term pain relief and improve physical function without affecting motor nerves. |
| Vertebroplasty | Active comparator | Procedure: Vertebroplasty, Procedure: KyphoplastyMinimally invasive image-guided procedure with percutaneous injection of bone cement into the fractured vertebral body. The cement hardens quickly, stabilizing the fracture, strengthening the vertebra, and providing rapid pain relief by preventing further micro-movements at the fracture site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years-old
- Subjects who are able to give informed consent and to understand and comply with study requirements.
- Predominantly axial back and low back pain ≥ 1 month in duration with no radicular pain below the knee that failed to conservative therapy.
- Subjects who have chronic back pain attributed to vertebral compression fractures (AO Spine A1 or A2 fractures) based on clinical evaluation (CT or MRI).
Key exclusion criteria (10 listed)
- Subjects who decline to provide written consent or follow-up.
- Subjects who are pregnant.
- Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
- Subjects who have an active systemic or local infection.
- Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
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 |
|---|---|---|
| Thermal facet ablationA minimally invasive procedure that uses heat radiofrequency) to target and disable the sensory nerves around damaged facet joints in the spine, stopping pain signals to the brain for relief from chronic back pain, stiffness, and limited mobility, with minimal scarring and quick recovery, often done with local anesthetic. | Procedure or surgery | thermal facet ablation |
| VertebroplastyA minimally invasive procedure to treat painful spinal compression fractures, by injecting special bone cement (polymethyl methacrylate) into the fractured vertebra using a needle guided by imaging (fluoroscopy) for stabilization and pain relief. | Procedure or surgery | Vertebroplasty |
| KyphoplastyA minimally invasive spine procedure to treat painful vertebral compression fractures by using a balloon to restore height to a collapsed vertebra, then filling the space with bone cement. The surgeon inserts a tube, inflates a balloon to create space and realign the bone, removes the balloon, and injects cement, all guided by real-time X-rays (fluoroscopy). | Procedure or surgery | Vertebroplasty |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 2 days after the treatment
Visual Analog Scale (VAS) Pain Score 2-day After Procedure, VAS Score Evaluation 0: No pain 1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain
1 secondary outcome
Visual Analog Scale (VAS) 2 months
Time frame: 2 months after the procedure
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 26 May 2026.
- Individual participant dataSharing planned: No
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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.
Tamás Tóth, MD principal investigator
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal facet ablation, Vertebroplasty and Kyphoplasty in people with Vertebral Compression Fracture, run by Szeged University at 1 site in Hungary.
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 4 inclusion and 10 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 2 days after the treatment). 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 26 May 2026.