Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation.

NCT07507565 — Not applicable, Completed, 1000 participants, Szeged University

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Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty, Stentoplasty and Kyphoplasty Versus Thermal Facet Ablation.

Registry	NCT07507565
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1000 (Actual)
Sponsor	Szeged University (Other)
Conditions	Vertebral Compression Fracture
Interventions	Thermal facet ablation, Vertebroplasty, Kyphoplasty (Procedure)
Dates	start 2020-12-15, primary completion 2025-07-31, completion 2026-04-20, first posted 2026-04-02, last updated 2026-05-26
Locations	1 site in Hungary

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
thermal facet ablation	Active comparator	Procedure: Thermal facet ablation	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.
Vertebroplasty	Active comparator	Procedure: Vertebroplasty; Procedure: Kyphoplasty	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.

Thermal facet ablation (Procedure): 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.
Vertebroplasty (Procedure): 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.
Kyphoplasty (Procedure): 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).

+Outcome measures

Primary outcomes

Visual Analog Scale (VAS) [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

Secondary outcomes

Visual Analog Scale (VAS) 2 months [2 months after the procedure]: 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

Other outcomes

Visual Analog Scale (VAS) Pain Score 6-month [6 months after the procedure]: Visual Analog Scale (VAS) Pain Score 6 months After Procedure VAS Score Evaluation 0: No pain 1 - 3 Mild pain 4 - 6 Moderate pain 7 - 10 Severe pain

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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)
* 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.

+Locations (1)

Facility	City	Country	Status
Department of Neurosurgery	Szeged, Csongrád megye	Hungary

+Investigators

Tamás Tóth, MD, Principal investigator, Szeged University

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