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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamás Tóth, MD | Szeged University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery | Szeged | Csongrád megye | 6725 | Hungary |
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| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D058498 | Kyphoplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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. |
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| 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). |
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