| Primary | Back Pain Change From Baseline at 3 Months | Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3 months after surgery | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
| | | Title | Denominators | Categories |
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| Back pain at baseline | | | | Back pain at 3 Months | |
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| Primary | Back Function Change From Baseline by Oswestry Disability Index at 3 Months | ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3 months after surgery | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Primary | SF-36v2 Physical Component Summary Change From Baseline at 3 Months | Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3 months after surgery | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Primary | Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months | EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 3 months after surgery | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Back Pain | Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Back Function (ODI) | ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 30 days, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Quality of Life by SF-36v2 PCS | Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 30 days, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Quality of Life by EQ-5D Index Score | | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 30 days, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Number | | percentage of participants | | Baseline, 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | days | | Baseline, 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Ambulatory Status | | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Number | | percentage of participants | | Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices |
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| Secondary | Barthel Index (Only for Subjects With Osteoporosis) | For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability). | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 30 days, 3 months 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Karnofsky Performance Scale | For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 30 days, 3 months 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body. | A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | percentage of pre-fracture height | | Baseline, pre-discharge, 3 months, and 12 months | Treated levels | Treated levels | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Vertebral Body Angle | The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. | A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | degrees | | Baseline, pre-discharge, 3 months, and 12 months | Treated levels | Treated levels | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Local Cobb Angle | The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. | A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Mean | Standard Deviation | degrees | | Baseline, pre-discharge, 3 months, and 12 months | Treated levels | Treated levels | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Subsequent Radiographic Fractures | A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Number | | percentage of participants | | 3 months and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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| Secondary | Neurological Success Rate | Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components. | The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc. | Posted | | Number | | percentage of participants | | Pre-discharge, 30 days, 3 months, 6 months, and 12 months | | | | ID | Title | Description |
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| OG000 | Balloon Kyphoplasty | This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices. |
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