Vertebral Body Compression Fractures
Conditions
Keywords
Kyphoplasty, Vertebroplasty, Balloon Kyphoplasty, Inflatable Bone Tamp, Spine, Back Pain, Vertebral Compression Fracture, Vertebral Body Compression Fracture
Brief summary
Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.
Detailed description
Medtronic Spine LLC is sponsoring the KAVIAR study, a randomized clinical trial comparing balloon kyphoplasty to vertebroplasty for the treatment of osteoporotic vertebral body compression fractures (VCFs). Up to 1,234 subjects at up to 75 study centers with one to three VCFs and VB morphologies suitable for both balloon kyphoplasty and vertebroplasty will be randomly assigned to receive one or the other procedure. Study visits will occur at baseline, 30 days postoperatively, and at 3, 12 and 24 months postoperatively. At all visits, adverse events, back pain, back function and quality of life will be assessed. In addition, a 7-day phone call will be conducted, which will include assessment of back pain, narcotic use and adverse events. At baseline, pre-discharge, 3-, 12- and 24-month visits, lateral spine x-rays will be taken. The primary endpoint will be the proportion of patients with one or more subsequent fractures at 12 and 24 months, detected radiographically as determined by a core radiology laboratory. Secondary clinical endpoints include changes from baseline in back pain, back function and quality of life, and adverse events. Secondary radiographic comparisons include the restoration and maintenance of VB height and angulation, and sagittal vertical axis, a measure of global sagittal balance. A postoperative CT scan will be evaluated to detect cement extravasation and to examine the relationship between cement distribution and clinical outcomes. Another important feature of the study is a detailed healthcare utilization data assessment. Combined with a costing methodology based on Medicare cost data and other sources, cumulative two-year healthcare costs related to VCF will be estimated. Combined with quality of life measurements, the cost analysis will allow a calculation of the relative cost-effectiveness of balloon kyphoplasty and vertebroplasty. Sample size is based on the primary endpoint, the proportion with subsequent fractures at 12 and 24 months.
Interventions
PROCEDUREVertebroplasty
Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
PROCEDUREKyphoplasty
Balloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement.
Sponsors
Medtronic Spine LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects must meet all of the following criteria to be enrolled into the study: 1. Age \> 21 2. 1 to 3 target VCFs meeting the following criteria: 1. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis 2. All target VCFs are between T5 and L5 3. All target VCFs to be treated show either: i. Height change: An acute (\< 6 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 1 or more grades by the Genant criteria (17), OR ii. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI or target VB is positive on radionuclide bone scan 4. All VCFs to be treated have fracture age (time from pain onset to evaluation by the Investigator) of 6 months or less 5. Back pain correlating with the location of at least one VCF 3. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty. (Team approach only: Both the vertebroplasty and balloon kyphoplasty physician have reviewed radiographic studies and agree to this prior to enrolling the subject in the study.) 4. Pre-treatment back pain by numerical rating scale (NRS) score \> 4 (0-10 scale) 5. Pre-treatment Oswestry Disability Index \>20 (0 - 100 scale) 6. Subject states availability for all study visits 7. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent 8. Subject has mental capacity to comply with the protocol requirements for 2-year duration of study
Exclusion criteria
Subjects who meet any of the following conditions may not be enrolled into the study: 1. VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs 2. Fracture due to high-energy trauma 3. Suspected OR proven cancer inside index vertebral body. Note that patients with chemotherapy-related osteoporosis may be included. 4. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis) 5. Any painful VCF with fracture age \> 6 months 6. Any objective evidence of neurologic compromise at baseline 7. Previous balloon kyphoplasty or vertebroplasty for any VCF 8. Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted VCFs 9. Significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness) 10. Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as: 1. Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants. 2. Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty or vertebroplasty. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used. 3. Any evidence of VB or systemic infection 11. Pregnant or child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months | 12 months |
| Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Posterior Vertebral Body Height | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | — |
| Back Pain | 7 days, 30 days, 3 months, 12 months, 24 months post-operation | Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). |
| Back Function-Oswestry Disability Index | 30 days, 3 months, 12 months, 24 months post-operation | The Oswestry Disability Index (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-36 | 30 days, 3 months, 12 months, 24 months post-operation | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. |
| Quality of Life -- EQ5D Index | 30 days, 3 months, 12 months, 24 months post-operation | EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. |
| Change in Anterior Vertebral Body Height | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | — |
| Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days | 30 days post-operation | Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment. |
| Change in Vertebral Body Kyphosis Angle | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body. |
| Change in Vertebral Body Local Cobb Angle (LCA) | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body. |
| Change in Global Sagittal Balance. | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | Change in global sagittal balance as measured by sagittal vertical axis. |
| VCF-related Health Care Utilization | Monthly for 24 months post-op | Health care utilization assessments conducted by monthly phone call to participating patients. |
| Rate of Serious Adverse Events at 30 Days | 30 days post-operation | Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention. |
| Change in Middle Vertebral Body Height | Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kyphoplasty This group of patients has received balloon kyphoplasty procedure. | 191 |
| Vertebroplasty This group of patients has received vertebroplasty procedure. | 190 |
| Total | 381 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 16 | 21 | 0 | 0 |
| Overall Study | Logistical withdrawal | 9 | 5 | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 10 | 0 | 0 |
| Overall Study | Other non-VCF-related medical condition | 3 | 2 | 0 | 0 |
| Overall Study | Other reason | 11 | 8 | 4 | 9 |
| Overall Study | Physician Decision | 2 | 0 | 0 | 1 |
| Overall Study | Sponsor discontinued trial | 29 | 29 | 0 | 0 |
| Overall Study | Unrelenting or severe back pain | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 23 | 4 | 4 |
Baseline characteristics
| Characteristic | Vertebroplasty | Kyphoplasty | Total |
|---|---|---|---|
| Age, Continuous | 75.7 years STANDARD_DEVIATION 10.5 | 75.5 years STANDARD_DEVIATION 10.3 | 75.6 years STANDARD_DEVIATION 10.4 |
| Current Height | 64.5 inches STANDARD_DEVIATION 4 | 63.8 inches STANDARD_DEVIATION 4.3 | 64.1 inches STANDARD_DEVIATION 4.2 |
| Current Weight | 160.2 lbs STANDARD_DEVIATION 42.9 | 154.0 lbs STANDARD_DEVIATION 40.2 | 157.1 lbs STANDARD_DEVIATION 41.6 |
| Number of patients with intend to treat VCFs One level of VCFs intend to treat | 150 participants | 149 participants | 299 participants |
| Number of patients with intend to treat VCFs Three levels of VCFs intend to treat | 8 participants | 9 participants | 17 participants |
| Number of patients with intend to treat VCFs Two levels of VCFs intend to treat | 32 participants | 33 participants | 65 participants |
| Osteoporosis Cause Suspected or confirmed primary osteoporosis | 172 participants | 179 participants | 351 participants |
| Osteoporosis Cause Suspected or confirmed secondary osteoporosis | 18 participants | 12 participants | 30 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 8 participants | 10 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 181 participants | 178 participants | 359 participants |
| Sex: Female, Male Female | 144 Participants | 151 Participants | 295 Participants |
| Sex: Female, Male Male | 46 Participants | 40 Participants | 86 Participants |
| Smoking Habit Current Smoker | 22 participants | 31 participants | 53 participants |
| Smoking Habit Former Smoker | 84 participants | 68 participants | 152 participants |
| Smoking Habit Never Smoked | 84 participants | 92 participants | 176 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 191 | 69 / 190 |
| serious Total, serious adverse events | 125 / 191 | 125 / 190 |
Outcome results
Primary
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
Time frame: 24 months
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kyphoplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months | No subsequence VCF | 50.9 percentage of participants |
| Kyphoplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months | One or more subsequence VCFs | 49.1 percentage of participants |
| Vertebroplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months | One or more subsequence VCFs | 57.7 percentage of participants |
| Vertebroplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months | No subsequence VCF | 42.3 percentage of participants |
p-value: 0.226Fisher Exact
Primary
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
Time frame: 12 months
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kyphoplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months | No subsequent VCF | 64.3 percentage of participants |
| Kyphoplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months | One or more subsequent VCFs | 35.7 percentage of participants |
| Vertebroplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months | No subsequent VCF | 56.5 percentage of participants |
| Vertebroplasty | Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months | One or more subsequent VCFs | 43.5 percentage of participants |
p-value: 0.214Fisher Exact
Secondary
Back Function-Oswestry Disability Index
The Oswestry Disability Index (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: 30 days, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Back Function-Oswestry Disability Index | ODI at baseline (n=191, 189) | 59.0 units on a scale | Standard Deviation 17.5 |
| Kyphoplasty | Back Function-Oswestry Disability Index | ODI at 12 months (n=138, 119) | 29.2 units on a scale | Standard Deviation 18.1 |
| Kyphoplasty | Back Function-Oswestry Disability Index | ODI at 3 months (n=153, 141) | 30.4 units on a scale | Standard Deviation 18.6 |
| Kyphoplasty | Back Function-Oswestry Disability Index | ODI at 24 months (n=108, 93) | 32.1 units on a scale | Standard Deviation 19.4 |
| Kyphoplasty | Back Function-Oswestry Disability Index | ODI at 30 days (n=164, 156) | 36.2 units on a scale | Standard Deviation 19.8 |
| Vertebroplasty | Back Function-Oswestry Disability Index | ODI at 24 months (n=108, 93) | 30.8 units on a scale | Standard Deviation 17.8 |
| Vertebroplasty | Back Function-Oswestry Disability Index | ODI at baseline (n=191, 189) | 57.8 units on a scale | Standard Deviation 16 |
| Vertebroplasty | Back Function-Oswestry Disability Index | ODI at 30 days (n=164, 156) | 34.6 units on a scale | Standard Deviation 17.6 |
| Vertebroplasty | Back Function-Oswestry Disability Index | ODI at 3 months (n=153, 141) | 30.8 units on a scale | Standard Deviation 18 |
| Vertebroplasty | Back Function-Oswestry Disability Index | ODI at 12 months (n=138, 119) | 28.2 units on a scale | Standard Deviation 17.8 |
Comparison: Statistical analysis at 30 daysp-value: 0.785ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.393ANCOVA
Comparison: Statistical analysis at 12 monthsp-value: 0.875ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.833ANCOVA
Secondary
Back Pain
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Time frame: 7 days, 30 days, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Back Pain | Back pain at baseline (n=191, 190) | 7.8 units on a scale | Standard Deviation 1.8 |
| Kyphoplasty | Back Pain | Back pain at 7days (n=184, 180) | 4.2 units on a scale | Standard Deviation 2.8 |
| Kyphoplasty | Back Pain | Back pain at 30 days (n=169, 173) | 3.6 units on a scale | Standard Deviation 2.9 |
| Kyphoplasty | Back Pain | Back pain at 3 months (n=158, 156) | 3.3 units on a scale | Standard Deviation 3 |
| Kyphoplasty | Back Pain | Back pain at 12 months (n=142, 133) | 3.2 units on a scale | Standard Deviation 3 |
| Kyphoplasty | Back Pain | Back pain at 24 months (n=112, 108) | 3.7 units on a scale | Standard Deviation 3.2 |
| Vertebroplasty | Back Pain | Back pain at 12 months (n=142, 133) | 3.5 units on a scale | Standard Deviation 2.9 |
| Vertebroplasty | Back Pain | Back pain at baseline (n=191, 190) | 7.7 units on a scale | Standard Deviation 1.8 |
| Vertebroplasty | Back Pain | Back pain at 3 months (n=158, 156) | 3.2 units on a scale | Standard Deviation 2.8 |
| Vertebroplasty | Back Pain | Back pain at 7days (n=184, 180) | 4.0 units on a scale | Standard Deviation 2.5 |
| Vertebroplasty | Back Pain | Back pain at 24 months (n=112, 108) | 3.8 units on a scale | Standard Deviation 3 |
| Vertebroplasty | Back Pain | Back pain at 30 days (n=169, 173) | 3.5 units on a scale | Standard Deviation 2.7 |
Comparison: Statistical analysis at 7 days.p-value: 0.43ANCOVA
Comparison: Statistical analysis at 30 days.p-value: 0.655ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.756ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.503ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.837ANCOVA
Secondary
Change in Anterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Change in Anterior Vertebral Body Height | Change from pre-op to pre-discharge (n=217, 200) | 2.51 mm | Standard Deviation 3.19 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Estimated Pre-Fracture (EP) height (n=231, 222) | 24.32 mm | Standard Deviation 3.93 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 3 months (n=176, 157) | 1.26 mm | Standard Deviation 2.99 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Height Loss from EP/Absolute Height Loss (AHL) | -8.43 mm | Standard Deviation 4.47 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 12 months (n=158, 128) | 1.33 mm | Standard Deviation 3.12 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 24 months (n=101, 93) | 1.00 mm | Standard Deviation 3.08 |
| Kyphoplasty | Change in Anterior Vertebral Body Height | Vertebral body height at Pre-op (n=224, 212) | 15.91 mm | Standard Deviation 5.79 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 24 months (n=101, 93) | 0.75 mm | Standard Deviation 3.05 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Estimated Pre-Fracture (EP) height (n=231, 222) | 24.49 mm | Standard Deviation 4.09 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Vertebral body height at Pre-op (n=224, 212) | 15.15 mm | Standard Deviation 6.04 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Height Loss from EP/Absolute Height Loss (AHL) | -9.22 mm | Standard Deviation 5.15 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Change from pre-op to pre-discharge (n=217, 200) | 2.40 mm | Standard Deviation 3.03 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 3 months (n=176, 157) | 1.23 mm | Standard Deviation 3.13 |
| Vertebroplasty | Change in Anterior Vertebral Body Height | Change from pre-op to 12 months (n=158, 128) | 1.05 mm | Standard Deviation 2.96 |
Comparison: Statistical analysis at pre-discharge.p-value: 0.112ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.364ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.185ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.1ANCOVA
Secondary
Change in Global Sagittal Balance.
Change in global sagittal balance as measured by sagittal vertical axis.
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.
Secondary
Change in Middle Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Change in Middle Vertebral Body Height | Height loss from EP/ Absolute Height Loss (AHL) | -7.42 mm | Standard Deviation 4.06 |
| Kyphoplasty | Change in Middle Vertebral Body Height | Change from pre-op at 3 months (n=177, 159) | 1.34 mm | Standard Deviation 2.59 |
| Kyphoplasty | Change in Middle Vertebral Body Height | Vertebral body height at pre-op (n=225, 211) | 16.08 mm | Standard Deviation 5.08 |
| Kyphoplasty | Change in Middle Vertebral Body Height | Change from pre-op at 12 months (n=161, 128) | 1.31 mm | Standard Deviation 2.8 |
| Kyphoplasty | Change in Middle Vertebral Body Height | change from pre-op at pre-discharge (n=219, 200) | 2.33 mm | Standard Deviation 2.72 |
| Kyphoplasty | Change in Middle Vertebral Body Height | Change from pre-op at 24 months (n=104, 92) | 0.98 mm | Standard Deviation 2.58 |
| Kyphoplasty | Change in Middle Vertebral Body Height | Estimated Pre-Fracture Height (EP) (n=231, 222) | 23.45 mm | Standard Deviation 3.46 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Change from pre-op at 24 months (n=104, 92) | 0.67 mm | Standard Deviation 2.78 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Estimated Pre-Fracture Height (EP) (n=231, 222) | 23.68 mm | Standard Deviation 3.58 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Vertebral body height at pre-op (n=225, 211) | 15.92 mm | Standard Deviation 5.12 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Height loss from EP/ Absolute Height Loss (AHL) | -7.60 mm | Standard Deviation 4.09 |
| Vertebroplasty | Change in Middle Vertebral Body Height | change from pre-op at pre-discharge (n=219, 200) | 1.84 mm | Standard Deviation 2.38 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Change from pre-op at 3 months (n=177, 159) | 1.18 mm | Standard Deviation 2.55 |
| Vertebroplasty | Change in Middle Vertebral Body Height | Change from pre-op at 12 months (n=161, 128) | 0.92 mm | Standard Deviation 2.51 |
Comparison: Statistical analysis at pre-discharge.p-value: 0.005ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.382ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.196ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.281ANCOVA
Secondary
Change in Posterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Change in Posterior Vertebral Body Height | Height Loss from EP/Absolute Height Loss (AHL) | -2.52 mm | Standard Deviation 2.47 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 3 months (n=179, 160) | 0.10 mm | Standard Deviation 1.64 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Vertebral body height at pre-op (n=225, 210) | 23.41 mm | Standard Deviation 4.11 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 12 months (n=161, 129) | -0.03 mm | Standard Deviation 1.79 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Change from pre-op to pre-discharge (n=220, 199) | 0.82 mm | Standard Deviation 1.74 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 24 months (n=104, 93) | -0.21 mm | Standard Deviation 1.55 |
| Kyphoplasty | Change in Posterior Vertebral Body Height | Estimated Pre-Fracture Height (n=231, 222) | 25.89 mm | Standard Deviation 3.45 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 24 months (n=104, 93) | -0.30 mm | Standard Deviation 1.79 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Estimated Pre-Fracture Height (n=231, 222) | 26.10 mm | Standard Deviation 3.67 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Vertebral body height at pre-op (n=225, 210) | 23.47 mm | Standard Deviation 4.36 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Height Loss from EP/Absolute Height Loss (AHL) | -2.49 mm | Standard Deviation 2.46 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Change from pre-op to pre-discharge (n=220, 199) | 0.49 mm | Standard Deviation 1.5 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 3 months (n=179, 160) | 0.06 mm | Standard Deviation 1.63 |
| Vertebroplasty | Change in Posterior Vertebral Body Height | Change from pre-op to 12 months (n=161, 129) | -0.00 mm | Standard Deviation 1.78 |
Comparison: Statistical analysis at pre-discharge.p-value: 0.033ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.981ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.631ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.79ANCOVA
Secondary
Change in Vertebral Body Kyphosis Angle
The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to pre-discharge (n=213, 195) | 3.10 degree | Standard Deviation 5.22 |
| Kyphoplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 12 months (n=154, 127) | 1.97 degree | Standard Deviation 5.38 |
| Kyphoplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 3 months (n=168, 155) | 1.78 degree | Standard Deviation 5.25 |
| Kyphoplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 24 months (n=99, 92) | 2.09 degree | Standard Deviation 5.95 |
| Kyphoplasty | Change in Vertebral Body Kyphosis Angle | Kyphosis angle at pre-op (n=219, 210) | -14.17 degree | Standard Deviation 8.29 |
| Vertebroplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 24 months (n=99, 92) | 1.43 degree | Standard Deviation 5.01 |
| Vertebroplasty | Change in Vertebral Body Kyphosis Angle | Kyphosis angle at pre-op (n=219, 210) | -15.68 degree | Standard Deviation 8.12 |
| Vertebroplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to pre-discharge (n=213, 195) | 3.41 degree | Standard Deviation 5.67 |
| Vertebroplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 3 months (n=168, 155) | 2.28 degree | Standard Deviation 5.72 |
| Vertebroplasty | Change in Vertebral Body Kyphosis Angle | Change from pre-op to 12 months (n=154, 127) | 1.51 degree | Standard Deviation 5.3 |
Comparison: Statistical analysis at pre-discharge.p-value: 0.663ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.933ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.089ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.036ANCOVA
Secondary
Change in Vertebral Body Local Cobb Angle (LCA)
The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to pre-discharge (n=203, 186) | 2.37 degree | Standard Deviation 5.84 |
| Kyphoplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 12 months (n=151, 118) | 0.38 degree | Standard Deviation 10.15 |
| Kyphoplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 3 months (n=166, 146) | -0.22 degree | Standard Deviation 5.46 |
| Kyphoplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 24 months (n=98, 85) | -1.15 degree | Standard Deviation 8.43 |
| Kyphoplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Vertebral body LCA at pre-op (n=213, 203) | -14.00 degree | Standard Deviation 19.71 |
| Vertebroplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 24 months (n=98, 85) | -0.57 degree | Standard Deviation 6.35 |
| Vertebroplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Vertebral body LCA at pre-op (n=213, 203) | -15.48 degree | Standard Deviation 18.67 |
| Vertebroplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to pre-discharge (n=203, 186) | 2.84 degree | Standard Deviation 4.33 |
| Vertebroplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 3 months (n=166, 146) | -0.43 degree | Standard Deviation 6.67 |
| Vertebroplasty | Change in Vertebral Body Local Cobb Angle (LCA) | Change from pre-op to 12 months (n=151, 118) | 0.03 degree | Standard Deviation 8.15 |
Comparison: Statistical analysis at pre-discharge.p-value: 0.472ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.745ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.565ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.687ANCOVA
Secondary
Quality of Life by SF-36
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.
Time frame: 30 days, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Quality of Life by SF-36 | SF-36 PCS at 12 months (n=138, 118) | 36.07 units on a scale | Standard Deviation 11.33 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 MCS at baseline (n=189, 190) | 40.87 units on a scale | Standard Deviation 13.37 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 PCS at 3 months (n=153, 138) | 36.06 units on a scale | Standard Deviation 11.32 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 MCS at 30 days (n=162, 155) | 46.56 units on a scale | Standard Deviation 12.83 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 PCS at 24 months (n=108, 92) | 34.94 units on a scale | Standard Deviation 11.81 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 MCS at 3 months (n=153, 138) | 49.86 units on a scale | Standard Deviation 11.62 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 PCS at 30 days (n=162, 155) | 33.09 units on a scale | Standard Deviation 10.13 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 MCS at 12 months (n=138, 118) | 50.84 units on a scale | Standard Deviation 11.75 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 MCS at 24 months (n=108, 92) | 48.84 units on a scale | Standard Deviation 13.35 |
| Kyphoplasty | Quality of Life by SF-36 | SF-36 PCS at baseline (n=189, 190) | 27.92 units on a scale | Standard Deviation 7.46 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 MCS at 24 months (n=108, 92) | 48.66 units on a scale | Standard Deviation 12.24 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 PCS at baseline (n=189, 190) | 27.78 units on a scale | Standard Deviation 8.2 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 PCS at 30 days (n=162, 155) | 34.51 units on a scale | Standard Deviation 9.69 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 PCS at 3 months (n=153, 138) | 36.27 units on a scale | Standard Deviation 10.66 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 PCS at 12 months (n=138, 118) | 37.39 units on a scale | Standard Deviation 11.09 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 PCS at 24 months (n=108, 92) | 35.10 units on a scale | Standard Deviation 9.98 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 MCS at 12 months (n=138, 118) | 49.99 units on a scale | Standard Deviation 11.14 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 MCS at baseline (n=189, 190) | 43.38 units on a scale | Standard Deviation 12.73 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 MCS at 30 days (n=162, 155) | 47.43 units on a scale | Standard Deviation 12.23 |
| Vertebroplasty | Quality of Life by SF-36 | SF-36 MCS at 3 months (n=153, 138) | 49.85 units on a scale | Standard Deviation 11.16 |
Comparison: Statistical analysis of SF-36 PCS result at 30 days.p-value: 0.18ANCOVA
Comparison: Statistical analysis of SF-36 PCS result at 3 monthsp-value: 0.822ANCOVA
Comparison: Statistical analysis of SF-36 PCS result at 12 monthsp-value: 0.291ANCOVA
Comparison: Statistical analysis of SF-36 PCS result at 24 monthsp-value: 0.996ANCOVA
Comparison: Statistical analysis of SF-36 MCS result at 30 daysp-value: 0.983ANCOVA
Comparison: Statistical analysis of SF-36 MCS result at 3 monthsp-value: 0.576ANCOVA
Comparison: Statistical analysis of SF-36 MCS result at 12 monthsp-value: 0.393ANCOVA
Comparison: Statistical analysis of SF-36 MCS result at 24 monthsp-value: 0.722ANCOVA
Secondary
Quality of Life -- EQ5D Index
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Time frame: 30 days, 3 months, 12 months, 24 months post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kyphoplasty | Quality of Life -- EQ5D Index | EQ5D index at 30 days (n=164, 156) | 0.70 units on a scale | Standard Deviation 0.19 |
| Kyphoplasty | Quality of Life -- EQ5D Index | EQ5D index at 12 months (n=137, 119) | 0.76 units on a scale | Standard Deviation 0.18 |
| Kyphoplasty | Quality of Life -- EQ5D Index | EQ5D index at 3 months (n=152, 140) | 0.75 units on a scale | Standard Deviation 0.18 |
| Kyphoplasty | Quality of Life -- EQ5D Index | EQ5D index at 24 months (n=108, 94) | 0.72 units on a scale | Standard Deviation 0.22 |
| Kyphoplasty | Quality of Life -- EQ5D Index | EQ5D index at baseline (n=189,189) | 0.44 units on a scale | Standard Deviation 0.26 |
| Vertebroplasty | Quality of Life -- EQ5D Index | EQ5D index at 24 months (n=108, 94) | 0.74 units on a scale | Standard Deviation 0.19 |
| Vertebroplasty | Quality of Life -- EQ5D Index | EQ5D index at baseline (n=189,189) | 0.42 units on a scale | Standard Deviation 0.24 |
| Vertebroplasty | Quality of Life -- EQ5D Index | EQ5D index at 30 days (n=164, 156) | 0.71 units on a scale | Standard Deviation 0.19 |
| Vertebroplasty | Quality of Life -- EQ5D Index | EQ5D index at 3 months (n=152, 140) | 0.75 units on a scale | Standard Deviation 0.17 |
| Vertebroplasty | Quality of Life -- EQ5D Index | EQ5D index at 12 months (n=137, 119) | 0.77 units on a scale | Standard Deviation 0.16 |
Comparison: Statistical analysis at 30 days.p-value: 0.318ANCOVA
Comparison: Statistical analysis at 3 months.p-value: 0.523ANCOVA
Comparison: Statistical analysis at 12 months.p-value: 0.634ANCOVA
Comparison: Statistical analysis at 24 months.p-value: 0.457ANCOVA
Secondary
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days
Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.
Time frame: 30 days post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kyphoplasty | Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days | 4.2 percentage of participants |
| Vertebroplasty | Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days | 4.2 percentage of participants |
p-value: 1Fisher Exact
Secondary
Rate of Serious Adverse Events at 30 Days
Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Time frame: 30 days post-operation
Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kyphoplasty | Rate of Serious Adverse Events at 30 Days | 26.2 percentage of participants |
| Vertebroplasty | Rate of Serious Adverse Events at 30 Days | 27.4 percentage of participants |
p-value: 0.818Fisher Exact
Secondary
VCF-related Health Care Utilization
Health care utilization assessments conducted by monthly phone call to participating patients.
Time frame: Monthly for 24 months post-op
Population: Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.