Compression Fracture of Vertebral Body, Osteoporosis, Cancer
Conditions
Keywords
vertebral body compression fracture
Brief summary
The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.
Interventions
DEVICEBalloon 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.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Identified as an appropriate candidate for BKP and should have made the choice to have the procedure. 2. Must be Medicare Eligible (At least 65 years of age or otherwise eligible). 3. Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer. 4. Cancer patients should not have had a change in chemotherapy regimen within the last month, nor should they have a planned change within the next month from time of enrollment, with the exception of changes in dose. 5. All VCFs to be treated must have clinical pain symptoms (pain on palpation/percussion over the fractured vertebral body) that correlate with radiographic findings as follows: 1. Height change: An acute (≤ four month) change in VB height or morphology from a previous x-ray, CT or MRI, with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of one or more grades by the Genant criteria20, OR 2. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan. 6. All VCFs to be treated must have an estimated fracture age of four months or less. 7. Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty. 8. Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management. 9. Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale). 10. Must have life expectancy of ≥ 12 months. 11. Must declare availability for all study visits. 12. Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent. 13. Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.
Exclusion criteria
1. Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty. 2. VCFs due to high-energy trauma. 3. Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies. 4. VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors. 5. Platelet count of \<20,000/uL as measured at the time of hospital admission for the procedure. 6. Back pain due to causes other than acute fracture. 7. VCF with a clinically estimated (based on radiographic evidence as well as patient history) age of fracture \> four months. 8. VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise. 9. VCFs with the need for spinal surgery beyond balloon kyphoplasty. 10. Spinal cord compression or canal compromise requiring decompression. 11. Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up. 12. Pre-existing conditions contrary to balloon kyphoplasty such as: 1. Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure. 2. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection. 3. Irreversible coagulopathy or bleeding disorder. 13. Contraindications to both MRI and radionuclide bone scan. 14. Concurrent participation in another clinical study. 15. Pregnant or intending to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Back Pain Change From Baseline at 3 Months | Baseline, 3 months after surgery | 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. |
| Back Function Change From Baseline by Oswestry Disability Index at 3 Months | Baseline, 3 months after surgery | 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). |
| SF-36v2 Physical Component Summary Change From Baseline at 3 Months | Baseline, 3 months after surgery | 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. |
| Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months | Baseline, 3 months after surgery | EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | Baseline, 30 days, 3 months, 6 months, and 12 months | — |
| The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | Baseline, 30 days, 3 months, 6 months, and 12 months | — |
| Ambulatory Status | Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months | — |
| Barthel Index (Only for Subjects With Osteoporosis) | Baseline, 30 days, 3 months 6 months, and 12 months | 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). |
| Karnofsky Performance Scale | Baseline, 30 days, 3 months 6 months, and 12 months | 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. |
| Back Pain | Baseline, 7 days, 30 days, 6 months, 9 months, and 12 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. |
| Vertebral Body Angle | Baseline, pre-discharge, 3 months, and 12 months | 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. |
| Local Cobb Angle | Baseline, pre-discharge, 3 months, and 12 months | 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. |
| Subsequent Radiographic Fractures | 3 months and 12 months | 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. |
| Neurological Success Rate | Pre-discharge, 30 days, 3 months, 6 months, and 12 months | 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. |
| Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Baseline, pre-discharge, 3 months, and 12 months | 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. |
| Back Function (ODI) | Baseline, 30 days, 6 months, and 12 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). |
| Quality of Life by SF-36v2 PCS | Baseline, 30 days, 6 months, and 12 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. |
| Quality of Life by EQ-5D Index Score | Baseline, 30 days, 6 months, and 12 months | — |
Countries
United States
Participant flow
Recruitment details
A total of 354 subjects were enrolled in this study. Among them, 350 subjects had BKP surgery and 4 subjects were not treated with BKP. Two of the non-treated subjects voluntarily withdrew from the study and 2 subjects were lost-to-follow-up before surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 350 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 26 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Withdrawal by Subject | 49 |
Baseline characteristics
| Characteristic | Balloon Kyphoplasty |
|---|---|
| Age, Continuous | 78.9 years STANDARD_DEVIATION 8.1 |
| BMI | 26.1 kg/m^2 STANDARD_DEVIATION 5.5 |
| Estimated pre-fracture vertebral body height Anterior | 24.940 mm STANDARD_DEVIATION 4.811 |
| Estimated pre-fracture vertebral body height Middle | 24.207 mm STANDARD_DEVIATION 4.264 |
| Estimated pre-fracture vertebral body height Posterior | 26.502 mm STANDARD_DEVIATION 4.397 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 64.3 inches STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 330 Participants |
| Sex: Female, Male Female | 272 Participants |
| Sex: Female, Male Male | 78 Participants |
| Weight | 153.9 lbs STANDARD_DEVIATION 36.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 128 / 350 |
| serious Total, serious adverse events | 79 / 350 |
Outcome results
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).
Time frame: Baseline, 3 months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Back Function Change From Baseline by Oswestry Disability Index at 3 Months | ODI score at baseline | 63.4 units on a scale | Standard Deviation 14.9 |
| Balloon Kyphoplasty | Back Function Change From Baseline by Oswestry Disability Index at 3 Months | ODI score at 3 months | 27.1 units on a scale | Standard Deviation 18.8 |
| Balloon Kyphoplasty | Back Function Change From Baseline by Oswestry Disability Index at 3 Months | ODI change | -35.3 units on a scale | Standard Deviation 20.5 |
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.
Time frame: Baseline, 3 months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Back Pain Change From Baseline at 3 Months | Back pain at baseline | 8.7 units on a scale | Standard Deviation 1.2 |
| Balloon Kyphoplasty | Back Pain Change From Baseline at 3 Months | Back pain at 3 Months | 2.7 units on a scale | Standard Deviation 2.7 |
| Balloon Kyphoplasty | Back Pain Change From Baseline at 3 Months | Back pain change | -6.0 units on a scale | Standard Deviation 3 |
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.
Time frame: Baseline, 3 months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months | EQ-5D index at baseline | 0.383 units on a scale | Standard Deviation 0.212 |
| Balloon Kyphoplasty | Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months | EQ-5D index at 3 months | 0.746 units on a scale | Standard Deviation 0.194 |
| Balloon Kyphoplasty | Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months | EQ-5D index score change | 0.351 units on a scale | Standard Deviation 0.267 |
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.
Time frame: Baseline, 3 months after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | SF-36v2 Physical Component Summary Change From Baseline at 3 Months | SF-36 PCS at baseline | 24.2 units on a scale | Standard Deviation 7 |
| Balloon Kyphoplasty | SF-36v2 Physical Component Summary Change From Baseline at 3 Months | SF-36 PCS at 3 months | 36.6 units on a scale | Standard Deviation 11.2 |
| Balloon Kyphoplasty | SF-36v2 Physical Component Summary Change From Baseline at 3 Months | SF-36 PCS change | 12.4 units on a scale | Standard Deviation 11.4 |
Secondary
Ambulatory Status
Time frame: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 3 months | 34.1 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 3 months | 1.4 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 6 months | 62.4 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at baseline | 42.3 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at baseline | 50.3 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at baseline | 7.4 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 7 days | 59.9 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 7 days | 38.3 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 7 days | 1.8 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 30 days | 62.5 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 30 days | 36.2 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 30 days | 1.3 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 3 months | 64.5 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 6 months | 36.1 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 6 months | 1.5 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 9 months | 68.7 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 9 months | 30.9 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 9 months | 0.4 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Able to walk at 12 months | 63.2 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Walk with aid at 12months | 35.7 percentage of participants |
| Balloon Kyphoplasty | Ambulatory Status | Unable to walk at 12 months | 1.2 percentage of participants |
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).
Time frame: Baseline, 30 days, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Back Function (ODI) | ODI score at baseline | 63.4 units on a scale | Standard Deviation 14.9 |
| Balloon Kyphoplasty | Back Function (ODI) | ODI score at 30 days | 32.5 units on a scale | Standard Deviation 19.5 |
| Balloon Kyphoplasty | Back Function (ODI) | ODI score at 6 months | 25.7 units on a scale | Standard Deviation 19 |
| Balloon Kyphoplasty | Back Function (ODI) | ODI score at 12 months | 25.8 units on a scale | Standard Deviation 19 |
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.
Time frame: Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Back Pain | Back pain at baseline | 8.7 units on a scale | Standard Deviation 1.2 |
| Balloon Kyphoplasty | Back Pain | Back pain at 7 days | 3.4 units on a scale | Standard Deviation 2.3 |
| Balloon Kyphoplasty | Back Pain | Back pain at 30 days | 3.2 units on a scale | Standard Deviation 2.7 |
| Balloon Kyphoplasty | Back Pain | Back pain at 6 months | 2.5 units on a scale | Standard Deviation 2.7 |
| Balloon Kyphoplasty | Back Pain | Back pain at 9 months | 2.3 units on a scale | Standard Deviation 2.6 |
| Balloon Kyphoplasty | Back Pain | Back pain at 12 months | 2.4 units on a scale | Standard Deviation 2.8 |
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).
Time frame: Baseline, 30 days, 3 months 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Barthel Index (Only for Subjects With Osteoporosis) | Barthel index score at baseline | 16.2 units on a scale | Standard Deviation 4 |
| Balloon Kyphoplasty | Barthel Index (Only for Subjects With Osteoporosis) | Barthel index score at 30 days | 18.8 units on a scale | Standard Deviation 2.1 |
| Balloon Kyphoplasty | Barthel Index (Only for Subjects With Osteoporosis) | Barthel index score at 3 months | 19.1 units on a scale | Standard Deviation 2 |
| Balloon Kyphoplasty | Barthel Index (Only for Subjects With Osteoporosis) | Barthel index score at 6 months | 19.1 units on a scale | Standard Deviation 1.8 |
| Balloon Kyphoplasty | Barthel Index (Only for Subjects With Osteoporosis) | Barthel index score at 12 months | 19.1 units on a scale | Standard Deviation 1.8 |
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.
Time frame: Baseline, 30 days, 3 months 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Karnofsky Performance Scale | Karnofsky performance scale at baseline | 75.7 units on a scale | Standard Deviation 21.5 |
| Balloon Kyphoplasty | Karnofsky Performance Scale | Karnofsky performance scale at 30 days | 88.0 units on a scale | Standard Deviation 11 |
| Balloon Kyphoplasty | Karnofsky Performance Scale | Karnofsky performance scale at 3 months | 90.0 units on a scale | Standard Deviation 14.1 |
| Balloon Kyphoplasty | Karnofsky Performance Scale | Karnofsky performance scale at 6 months | 85.0 units on a scale | Standard Deviation 30 |
| Balloon Kyphoplasty | Karnofsky Performance Scale | Karnofsky performance scale at 12 months | 96.7 units on a scale | Standard Deviation 5.8 |
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.
Time frame: Baseline, pre-discharge, 3 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Local Cobb Angle | Local Cobb angle at baseline | -12.919 degrees | Standard Deviation 18.302 |
| Balloon Kyphoplasty | Local Cobb Angle | Local Cobb angle at pre-discharge | -11.190 degrees | Standard Deviation 17.244 |
| Balloon Kyphoplasty | Local Cobb Angle | Angle change from baseline at pre-discharge | 2.707 degrees | Standard Deviation 5.102 |
| Balloon Kyphoplasty | Local Cobb Angle | Local Cobb angle at 3 months | -13.439 degrees | Standard Deviation 17.843 |
| Balloon Kyphoplasty | Local Cobb Angle | Angle change from baseline at 3 months | 0.253 degrees | Standard Deviation 5.979 |
| Balloon Kyphoplasty | Local Cobb Angle | Local Cobb angle at 12 months | -12.819 degrees | Standard Deviation 18.643 |
| Balloon Kyphoplasty | Local Cobb Angle | Angle change from baseline at 12 months | -0.197 degrees | Standard Deviation 6.106 |
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.
Time frame: Pre-discharge, 30 days, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Neurological Success Rate | Neurological success at 3 months | 76.4 percentage of participants |
| Balloon Kyphoplasty | Neurological Success Rate | Neurological success at predischarge | 79.2 percentage of participants |
| Balloon Kyphoplasty | Neurological Success Rate | Neurological success at 30 days | 76.7 percentage of participants |
| Balloon Kyphoplasty | Neurological Success Rate | Neurological success at 6 months | 74.3 percentage of participants |
| Balloon Kyphoplasty | Neurological Success Rate | Neurological success at 12 months | 76.7 percentage of participants |
Secondary
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
Time frame: Baseline, 30 days, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | Baseline | 96.3 percentage of participants |
| Balloon Kyphoplasty | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | 30 days | 53.3 percentage of participants |
| Balloon Kyphoplasty | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | 3 months | 31.8 percentage of participants |
| Balloon Kyphoplasty | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | 6 months | 31.0 percentage of participants |
| Balloon Kyphoplasty | Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks | 12 months | 28.9 percentage of participants |
Secondary
Quality of Life by EQ-5D Index Score
Time frame: Baseline, 30 days, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Quality of Life by EQ-5D Index Score | EQ-5D index at baseline | 0.383 units on a scale | Standard Deviation 0.212 |
| Balloon Kyphoplasty | Quality of Life by EQ-5D Index Score | EQ-5D index at 30 days | 0.710 units on a scale | Standard Deviation 0.196 |
| Balloon Kyphoplasty | Quality of Life by EQ-5D Index Score | EQ-5D index at 6 months | 0.756 units on a scale | Standard Deviation 0.193 |
| Balloon Kyphoplasty | Quality of Life by EQ-5D Index Score | EQ-5D index at 12 months | 0.758 units on a scale | Standard Deviation 0.193 |
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.
Time frame: Baseline, 30 days, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Quality of Life by SF-36v2 PCS | SF-36 PCS at baseline | 24.2 units on a scale | Standard Deviation 7 |
| Balloon Kyphoplasty | Quality of Life by SF-36v2 PCS | SF-36 PCS at 30 days | 34.9 units on a scale | Standard Deviation 9.8 |
| Balloon Kyphoplasty | Quality of Life by SF-36v2 PCS | SF-36 PCS at 6 months | 37.6 units on a scale | Standard Deviation 11.5 |
| Balloon Kyphoplasty | Quality of Life by SF-36v2 PCS | SF-36 PCS at 12 months | 38.2 units on a scale | Standard Deviation 12.1 |
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.
Time frame: 3 months and 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Balloon Kyphoplasty | Subsequent Radiographic Fractures | Subsequent fractures at 3 months | 36.7 percentage of participants |
| Balloon Kyphoplasty | Subsequent Radiographic Fractures | Subsequent fractures at 12 months | 47.6 percentage of participants |
Secondary
The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;
Time frame: Baseline, 30 days, 3 months, 6 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of limited activities at baseline | 11.0 days | Standard Deviation 4.6 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of bed rest at baseline | 6.0 days | Standard Deviation 5.9 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of limited activities at 30 days | 4.7 days | Standard Deviation 5.7 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of bed rest at 30 days | 1.5 days | Standard Deviation 3.5 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of limited activities at 3 months | 2.6 days | Standard Deviation 4.6 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of bed rest at 3 months | 0.7 days | Standard Deviation 2.3 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of limited activities at 6 months | 2.6 days | Standard Deviation 4.8 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of bed rest at 6 months | 0.7 days | Standard Deviation 2.5 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of limited activities at 12 months | 2.2 days | Standard Deviation 4.5 |
| Balloon Kyphoplasty | The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; | days of bed rest at 12 months | 0.7 days | Standard Deviation 2.4 |
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.
Time frame: Baseline, pre-discharge, 3 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Vertebral Body Angle | vertebral body angle at baseline | -10.474 degrees | Standard Deviation 8.152 |
| Balloon Kyphoplasty | Vertebral Body Angle | Vertebral body angle at pre-discharge | -9.522 degrees | Standard Deviation 6.867 |
| Balloon Kyphoplasty | Vertebral Body Angle | Angle change from baseline at pre-discharge | 1.117 degrees | Standard Deviation 4.137 |
| Balloon Kyphoplasty | Vertebral Body Angle | Vertebral body angle at 3 months | -10.119 degrees | Standard Deviation 6.781 |
| Balloon Kyphoplasty | Vertebral Body Angle | Angle change from baseline at 3 months | 0.633 degrees | Standard Deviation 4.282 |
| Balloon Kyphoplasty | Vertebral Body Angle | Vertebral body angle at 12 months | -9.876 degrees | Standard Deviation 6.714 |
| Balloon Kyphoplasty | Vertebral Body Angle | Angle change from baseline at 12 months | 0.748 degrees | Standard Deviation 4.315 |
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.
Time frame: Baseline, pre-discharge, 3 months, and 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Anterior height Loss from EP at baseline | -26.438 percentage of pre-fracture height | Standard Deviation 22.008 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Middle height loss from EP at baseline | -27.719 percentage of pre-fracture height | Standard Deviation 20.861 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Posterior height loss from EP at baseline | -8.228 percentage of pre-fracture height | Standard Deviation 10.966 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Anterior AHRP at pre-discharge | 3.897 percentage of pre-fracture height | Standard Deviation 9.822 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Middle AHRP at pre-discharge | 4.205 percentage of pre-fracture height | Standard Deviation 9.783 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Posterior AHRP at pre-discharge | 1.280 percentage of pre-fracture height | Standard Deviation 7.28 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Anterior AHRP at 3 months | 1.511 percentage of pre-fracture height | Standard Deviation 10.426 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Middle AHRP at 3 months | 2.223 percentage of pre-fracture height | Standard Deviation 10.076 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Posterior AHRP at 3 months | 0.101 percentage of pre-fracture height | Standard Deviation 7.474 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Anterior AHRP at 12 months | 1.308 percentage of pre-fracture height | Standard Deviation 10.765 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Middle AHRP at 12 months | 1.567 percentage of pre-fracture height | Standard Deviation 10.453 |
| Balloon Kyphoplasty | Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) | Posterior AHRP at 12 months | -0.028 percentage of pre-fracture height | Standard Deviation 8.284 |