Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs… (NCT07507565) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Analgetic Therapies in Traumatic Vertebral Compression Fractures: Vertebroplasty vs Thermal Facet Ablation.
Hungary1,000 participantsStarted 2020-12-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.