An interventional study of Vertebroplasty and Kyphoplasty in Vertebral Body Compression Fractures, sponsored by Medtronic Spine LLC. Terminated at 26 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by Medtronic Spine LLC (part of Medtronic) · Not applicable, Interventional, and Prevention
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.
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.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's enrollment of 404 is above the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Medtronic Spine LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted before Medtronic Spine LLC became part of Medtronic.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects must meet all of the following criteria to be enrolled into the study:
1 to 3 target VCFs meeting the following criteria:
Exclusion Criteria
Subjects who meet any of the following conditions may not be enrolled into the study:
Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Kyphoplasty
Procedure: Vertebroplasty
Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.
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.
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months
Time frame: 12 months
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months
Time frame: 24 months
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
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
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
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
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
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
Change in Anterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Middle Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
Change in Posterior Vertebral Body Height
Time frame: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation
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
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
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
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
| Milestone | Kyphoplasty | Vertebroplasty | Kyphoplasty Not Treated Patients | Vertebroplasty Not Treated Patients |
|---|---|---|---|---|
| Started | 191 | 190 | 8 | 15 |
| Completed | 100 | 91 | 0 | 0 |
| Not completed | 91 | 99 | 8 | 15 |
| Withdrew: Death | 16 | 21 | 0 | 0 |
| Withdrew: Lost to follow-up | 9 | 10 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 11 | 23 | 4 | 4 |
| Withdrew: Other non-vcf-related medical condition | 3 | 2 | 0 | 0 |
| Withdrew: Sponsor discontinued trial | 29 | 29 | 0 | 0 |
| Withdrew: Unrelenting or severe back pain | 1 | 1 | 0 | 0 |
| Withdrew: Logistical withdrawal | 9 | 5 | 0 | 1 |
| Withdrew: Other reason | 11 | 8 | 4 | 9 |
| percentage of participants | Kyphoplasty | Vertebroplasty |
|---|---|---|
| No subsequent VCF | 64.3 | 56.5 |
| One or more subsequent VCFs | 35.7 | 43.5 |
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
| units on a scale | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Back pain at baseline (n=191, 190) | 7.8 ± 1.8 | 7.7 ± 1.8 |
| Back pain at 7days (n=184, 180) | 4.2 ± 2.8 | 4.0 ± 2.5 |
| Back pain at 30 days (n=169, 173) | 3.6 ± 2.9 | 3.5 ± 2.7 |
| Back pain at 3 months (n=158, 156) | 3.3 ± 3.0 | 3.2 ± 2.8 |
| Back pain at 12 months (n=142, 133) | 3.2 ± 3.0 | 3.5 ± 2.9 |
| Back pain at 24 months (n=112, 108) | 3.7 ± 3.2 | 3.8 ± 3.0 |
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).
| units on a scale | Kyphoplasty | Vertebroplasty |
|---|---|---|
| ODI at baseline (n=191, 189) | 59.0 ± 17.5 | 57.8 ± 16.0 |
| ODI at 30 days (n=164, 156) | 36.2 ± 19.8 | 34.6 ± 17.6 |
| ODI at 3 months (n=153, 141) | 30.4 ± 18.6 | 30.8 ± 18.0 |
| ODI at 12 months (n=138, 119) | 29.2 ± 18.1 | 28.2 ± 17.8 |
| ODI at 24 months (n=108, 93) | 32.1 ± 19.4 | 30.8 ± 17.8 |
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.
| units on a scale | Kyphoplasty | Vertebroplasty |
|---|---|---|
| SF-36 PCS at baseline (n=189, 190) | 27.92 ± 7.46 | 27.78 ± 8.20 |
| SF-36 PCS at 30 days (n=162, 155) | 33.09 ± 10.13 | 34.51 ± 9.69 |
| SF-36 PCS at 3 months (n=153, 138) | 36.06 ± 11.32 | 36.27 ± 10.66 |
| SF-36 PCS at 12 months (n=138, 118) | 36.07 ± 11.33 | 37.39 ± 11.09 |
| SF-36 PCS at 24 months (n=108, 92) | 34.94 ± 11.81 | 35.10 ± 9.98 |
| SF-36 MCS at baseline (n=189, 190) | 40.87 ± 13.37 | 43.38 ± 12.73 |
| SF-36 MCS at 30 days (n=162, 155) | 46.56 ± 12.83 | 47.43 ± 12.23 |
| SF-36 MCS at 3 months (n=153, 138) | 49.86 ± 11.62 | 49.85 ± 11.16 |
| SF-36 MCS at 12 months (n=138, 118) | 50.84 ± 11.75 | 49.99 ± 11.14 |
| SF-36 MCS at 24 months (n=108, 92) | 48.84 ± 13.35 | 48.66 ± 12.24 |
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
| units on a scale | Kyphoplasty | Vertebroplasty |
|---|---|---|
| EQ5D index at baseline (n=189,189) | 0.44 ± 0.26 | 0.42 ± 0.24 |
| EQ5D index at 30 days (n=164, 156) | 0.70 ± 0.19 | 0.71 ± 0.19 |
| EQ5D index at 3 months (n=152, 140) | 0.75 ± 0.18 | 0.75 ± 0.17 |
| EQ5D index at 12 months (n=137, 119) | 0.76 ± 0.18 | 0.77 ± 0.16 |
| EQ5D index at 24 months (n=108, 94) | 0.72 ± 0.22 | 0.74 ± 0.19 |
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.
| percentage of participants | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Rate of Serious Adverse Events at 30 Days | 26.2 | 27.4 |
| percentage of participants | Kyphoplasty | Vertebroplasty |
|---|---|---|
| No subsequence VCF | 50.9 | 42.3 |
| One or more subsequence VCFs | 49.1 | 57.7 |
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.
| percentage of participants | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days | 4.2 | 4.2 |
| mm | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Estimated Pre-Fracture (EP) height (n=231, 222) | 24.32 ± 3.93 | 24.49 ± 4.09 |
| Vertebral body height at Pre-op (n=224, 212) | 15.91 ± 5.79 | 15.15 ± 6.04 |
| Height Loss from EP/Absolute Height Loss (AHL) | -8.43 ± 4.47 | -9.22 ± 5.15 |
| Change from pre-op to pre-discharge (n=217, 200) | 2.51 ± 3.19 | 2.40 ± 3.03 |
| Change from pre-op to 3 months (n=176, 157) | 1.26 ± 2.99 | 1.23 ± 3.13 |
| Change from pre-op to 12 months (n=158, 128) | 1.33 ± 3.12 | 1.05 ± 2.96 |
| Change from pre-op to 24 months (n=101, 93) | 1.00 ± 3.08 | 0.75 ± 3.05 |
| mm | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Estimated Pre-Fracture Height (EP) (n=231, 222) | 23.45 ± 3.46 | 23.68 ± 3.58 |
| Vertebral body height at pre-op (n=225, 211) | 16.08 ± 5.08 | 15.92 ± 5.12 |
| Height loss from EP/ Absolute Height Loss (AHL) | -7.42 ± 4.06 | -7.60 ± 4.09 |
| change from pre-op at pre-discharge (n=219, 200) | 2.33 ± 2.72 | 1.84 ± 2.38 |
| Change from pre-op at 3 months (n=177, 159) | 1.34 ± 2.59 | 1.18 ± 2.55 |
| Change from pre-op at 12 months (n=161, 128) | 1.31 ± 2.80 | 0.92 ± 2.51 |
| Change from pre-op at 24 months (n=104, 92) | 0.98 ± 2.58 | 0.67 ± 2.78 |
| mm | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Estimated Pre-Fracture Height (n=231, 222) | 25.89 ± 3.45 | 26.10 ± 3.67 |
| Vertebral body height at pre-op (n=225, 210) | 23.41 ± 4.11 | 23.47 ± 4.36 |
| Height Loss from EP/Absolute Height Loss (AHL) | -2.52 ± 2.47 | -2.49 ± 2.46 |
| Change from pre-op to pre-discharge (n=220, 199) | 0.82 ± 1.74 | 0.49 ± 1.50 |
| Change from pre-op to 3 months (n=179, 160) | 0.10 ± 1.64 | 0.06 ± 1.63 |
| Change from pre-op to 12 months (n=161, 129) | -0.03 ± 1.79 | -0.00 ± 1.78 |
| Change from pre-op to 24 months (n=104, 93) | -0.21 ± 1.55 | -0.30 ± 1.79 |
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.
| degree | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Kyphosis angle at pre-op (n=219, 210) | -14.17 ± 8.29 | -15.68 ± 8.12 |
| Change from pre-op to pre-discharge (n=213, 195) | 3.10 ± 5.22 | 3.41 ± 5.67 |
| Change from pre-op to 3 months (n=168, 155) | 1.78 ± 5.25 | 2.28 ± 5.72 |
| Change from pre-op to 12 months (n=154, 127) | 1.97 ± 5.38 | 1.51 ± 5.30 |
| Change from pre-op to 24 months (n=99, 92) | 2.09 ± 5.95 | 1.43 ± 5.01 |
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.
| degree | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Vertebral body LCA at pre-op (n=213, 203) | -14.00 ± 19.71 | -15.48 ± 18.67 |
| Change from pre-op to pre-discharge (n=203, 186) | 2.37 ± 5.84 | 2.84 ± 4.33 |
| Change from pre-op to 3 months (n=166, 146) | -0.22 ± 5.46 | -0.43 ± 6.67 |
| Change from pre-op to 12 months (n=151, 118) | 0.38 ± 10.15 | 0.03 ± 8.15 |
| Change from pre-op to 24 months (n=98, 85) | -1.15 ± 8.43 | -0.57 ± 6.35 |
Change in global sagittal balance as measured by sagittal vertical axis.
No measurements were reported for this outcome.
Health care utilization assessments conducted by monthly phone call to participating patients.
No measurements were reported for this outcome.
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kyphoplasty | — | 125/191 (65.4%) | 55/191 (28.8%) |
| Vertebroplasty | — | 125/190 (65.8%) | 69/190 (36.3%) |
| Event | Kyphoplasty | Vertebroplasty |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 42/191 | 42/190 |
| FallInjury, poisoning and procedural complications | 30/191 | 32/190 |
| Thoracic vertebral fractureMusculoskeletal and connective tissue disorders | 19/191 | 19/190 |
| Urinary tract infectionInfections and infestations | 10/191 | 18/190 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 15/191 | 7/190 |
| PneumoniaInfections and infestations | 14/191 | 12/190 |
| Lumbar vertebral fractureMusculoskeletal and connective tissue disorders | 9/191 | 13/190 |
| Cardiac failure congestiveCardiac disorders | 6/191 | 10/190 |
| BronchitisInfections and infestations | 10/191 | 7/190 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 4/191 | 8/190 |
| Event | Kyphoplasty | Vertebroplasty |
|---|---|---|
| FallInjury, poisoning and procedural complications | 23/191 | 20/190 |
| Back painMusculoskeletal and connective tissue disorders | 9/191 | 19/190 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/191 | 5/190 |
| Procedural painInjury, poisoning and procedural complications | 5/191 | 2/190 |
| Rib fractureInjury, poisoning and procedural complications | 1/191 | 4/190 |
| BronchitisInfections and infestations | 0/191 | 3/190 |
| Back injuryInjury, poisoning and procedural complications | 0/191 | 3/190 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 2/191 | 3/190 |
| Neck painMusculoskeletal and connective tissue disorders | 3/191 | 3/190 |
| Thoracic vertebral fractureMusculoskeletal and connective tissue disorders | 3/191 | 3/190 |
| Age, Continuous(years) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Mean | 75.5 ± 10.3 | 75.7 ± 10.5 | 75.6 ± 10.4 |
| Sex: Female, Male(Participants) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Female | 151 | 144 | 295 |
| Male | 40 | 46 | 86 |
| Race/Ethnicity, Customized(participants) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 2 | 3 |
| Black or African American | 3 | 4 | 7 |
| Hispanic | 8 | 2 | 10 |
| White | 178 | 181 | 359 |
| Other | 1 | 0 | 1 |
| Current Weight(lbs) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Mean | 154.0 ± 40.2 | 160.2 ± 42.9 | 157.1 ± 41.6 |
| Current Height(inches) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Mean | 63.8 ± 4.3 | 64.5 ± 4.0 | 64.1 ± 4.2 |
| Smoking Habit(participants) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Never Smoked | 92 | 84 | 176 |
| Former Smoker | 68 | 84 | 152 |
| Current Smoker | 31 | 22 | 53 |
| Osteoporosis Cause(participants) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| Suspected or confirmed primary osteoporosis | 179 | 172 | 351 |
| Suspected or confirmed secondary osteoporosis | 12 | 18 | 30 |
| Number of patients with intend to treat VCFs(participants) | Kyphoplasty | Vertebroplasty | Total |
|---|---|---|---|
| One level of VCFs intend to treat | 149 | 150 | 299 |
| Two levels of VCFs intend to treat | 33 | 32 | 65 |
| Three levels of VCFs intend to treat | 9 | 8 | 17 |
This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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