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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00000214 | Other Identifier | USF Institutional Review Board |
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No enrollment
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| Name | Class |
|---|---|
| Medtronics, Inc. | INDUSTRY |
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The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.
This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled.
The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Arm | No Intervention | Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study. | |
| Balloon Kypholasty | Experimental |
| |
| Control Arm | Active Comparator | Non-surgical Management Treatment Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebral Augmentation with Balloon Kyphoplasty | Procedure | Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Vertebral Event | Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture) | Average of 12 months |
| Time to Pain Progression | Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture | Average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Vertebral Events | Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months | 12 months |
| Rate of Hospitalization | Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Vrionis, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Non-surgical Treatment | Other | Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s). |
|
| 12 months |
| Complications of Procedure | Complications of vertebral augmentation | Average of 12 months |
| Quality of Life Questionnaire Results | Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability | Average of 12 months |
| Changes in Pulmonary Function | Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture | Average of 12 months |
| Change in Kyphosis | Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant | Average of 12 months |
| Prognostic Ability of Bone Biomarkers | Prognostic ability of bone biomarkers for the prediction of vertebral events | Average of 12 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |