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

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Compression Fracture
• Intervention / Treatment: Procedure: Thermal facet ablation; Procedure: Vertebroplasty; Procedure: Kyphoplasty

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6725
      • Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Thermal facet ablation; 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.
Active Comparator: Vertebroplasty; 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.	Procedure: Vertebroplasty; 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.; Procedure: Kyphoplasty; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 days after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Score 6-month	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	6 months after the procedure

Collaborators and Investigators

• Sponsor: Szeged University
• Investigators: Principal Investigator: Tamás Tóth, MD, Szeged University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Cementoplasty; Vertebroplasty; Kyphoplasty
• Other Study ID Numbers: 4868/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No