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Clinical Trials/NCT07507565
NCT07507565CompletedNot Applicable

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

Szeged University1 site in 1 country1,000 target enrollmentStarted: December 15, 2020Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,000
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Investigators

Sponsor
Szeged University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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