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

NCT07507565 | Completed

• 1 other identifier: 4868/2020
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vertebral Compression Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Scale (VAS) 2 months

  2 months after the procedure

Other Outcomes (1)

• Visual Analog Scale (VAS) Pain Score 6-month

  6 months after the procedure

Study Arms (2)

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.

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.

Procedure: Vertebroplasty; Procedure: Kyphoplasty

Interventions

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.

thermal facet ablation

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.

Vertebroplasty

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).

Vertebroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

Department of Neurosurgery

Szeged, Csongrád megye, 6725, Hungary

Location

MeSH Terms

Interventions

Vertebroplasty; Kyphoplasty

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Tamás Tóth, MD

  Szeged University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: December 15, 2020
• Primary Completion: July 31, 2025
• Study Completion: April 20, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)