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Completed

NCT Number: NCT07507565

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

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Key information

Conditions

Vertebral Compression Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery

Szeged, Csongrád megye, 6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Visual Analog Scale (VAS) 2 months

    Time frame: 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

  1. Visual Analog Scale (VAS) Pain Score 6-month

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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