Vertebral Compression Fracture
Conditions
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.
Interventions
PROCEDUREThermal 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.
PROCEDUREVertebroplasty
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.
PROCEDUREKyphoplasty
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).
Sponsors
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORTamás Tóth, MD
Szeged University
Outcome results
None listed