An interventional study of Balloon kyphoplasty in Compression Fracture of Vertebral Body, Osteoporosis and Cancer, sponsored by Medtronic Spinal and Biologics. Completed at 25 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Medtronic Spinal and Biologics · Not applicable, Interventional, and Treatment
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.
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:
Exclusion Criteria:
Pre-existing conditions contrary to balloon kyphoplasty such as:
This group of patients will be treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.
Device: 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.
Also known as: BKP
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
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
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
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
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
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
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
Quality of Life by EQ-5D Index Score
Time frame: Baseline, 30 days, 6 months, and 12 months
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
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
Ambulatory Status
Time frame: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
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
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
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
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
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
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
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
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.
| Milestone | Balloon Kyphoplasty |
|---|---|
| Started | 350 |
| Completed | 260 |
| Not completed | 90 |
| Withdrew: Death | 26 |
| Withdrew: Lost to follow-up | 15 |
| Withdrew: Withdrawal by subject | 49 |
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."
| units on a scale | Balloon Kyphoplasty |
|---|---|
| Back pain at baseline | 8.7 ± 1.2 |
| Back pain at 3 Months | 2.7 ± 2.7 |
| Back pain change | -6.0 ± 3.0 |
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 | Balloon Kyphoplasty |
|---|---|
| ODI score at baseline | 63.4 ± 14.9 |
| ODI score at 3 months | 27.1 ± 18.8 |
| ODI change | -35.3 ± 20.5 |
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.
| units on a scale | Balloon Kyphoplasty |
|---|---|
| SF-36 PCS at baseline | 24.2 ± 7.0 |
| SF-36 PCS at 3 months | 36.6 ± 11.2 |
| SF-36 PCS change | 12.4 ± 11.4 |
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 | Balloon Kyphoplasty |
|---|---|
| EQ-5D index at baseline | 0.383 ± 0.212 |
| EQ-5D index at 3 months | 0.746 ± 0.194 |
| EQ-5D index score change | 0.351 ± 0.267 |
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."
| units on a scale | Balloon Kyphoplasty |
|---|---|
| Back pain at baseline | 8.7 ± 1.2 |
| Back pain at 7 days | 3.4 ± 2.3 |
| Back pain at 30 days | 3.2 ± 2.7 |
| Back pain at 6 months | 2.5 ± 2.7 |
| Back pain at 9 months | 2.3 ± 2.6 |
| Back pain at 12 months | 2.4 ± 2.8 |
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 | Balloon Kyphoplasty |
|---|---|
| ODI score at baseline | 63.4 ± 14.9 |
| ODI score at 30 days | 32.5 ± 19.5 |
| ODI score at 6 months | 25.7 ± 19.0 |
| ODI score at 12 months | 25.8 ± 19.0 |
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.
| units on a scale | Balloon Kyphoplasty |
|---|---|
| SF-36 PCS at baseline | 24.2 ± 7.0 |
| SF-36 PCS at 30 days | 34.9 ± 9.8 |
| SF-36 PCS at 6 months | 37.6 ± 11.5 |
| SF-36 PCS at 12 months | 38.2 ± 12.1 |
| units on a scale | Balloon Kyphoplasty |
|---|---|
| EQ-5D index at baseline | 0.383 ± 0.212 |
| EQ-5D index at 30 days | 0.710 ± 0.196 |
| EQ-5D index at 6 months | 0.756 ± 0.193 |
| EQ-5D index at 12 months | 0.758 ± 0.193 |
| percentage of participants | Balloon Kyphoplasty |
|---|---|
| Baseline | 96.3 |
| 30 days | 53.3 |
| 3 months | 31.8 |
| 6 months | 31.0 |
| 12 months | 28.9 |
| days | Balloon Kyphoplasty |
|---|---|
| days of limited activities at baseline | 11.0 ± 4.6 |
| days of bed rest at baseline | 6.0 ± 5.9 |
| days of limited activities at 30 days | 4.7 ± 5.7 |
| days of bed rest at 30 days | 1.5 ± 3.5 |
| days of limited activities at 3 months | 2.6 ± 4.6 |
| days of bed rest at 3 months | 0.7 ± 2.3 |
| days of limited activities at 6 months | 2.6 ± 4.8 |
| days of bed rest at 6 months | 0.7 ± 2.5 |
| days of limited activities at 12 months | 2.2 ± 4.5 |
| days of bed rest at 12 months | 0.7 ± 2.4 |
| percentage of participants | Balloon Kyphoplasty |
|---|---|
| Able to walk at baseline | 42.3 |
| Walk with aid at baseline | 50.3 |
| Unable to walk at baseline | 7.4 |
| Able to walk at 7 days | 59.9 |
| Walk with aid at 7 days | 38.3 |
| Unable to walk at 7 days | 1.8 |
| Able to walk at 30 days | 62.5 |
| Walk with aid at 30 days | 36.2 |
| Unable to walk at 30 days | 1.3 |
| Able to walk at 3 months | 64.5 |
| Walk with aid at 3 months | 34.1 |
| Unable to walk at 3 months | 1.4 |
| Able to walk at 6 months | 62.4 |
| Walk with aid at 6 months | 36.1 |
| Unable to walk at 6 months | 1.5 |
| Able to walk at 9 months | 68.7 |
| Walk with aid at 9 months | 30.9 |
| Unable to walk at 9 months | 0.4 |
| Able to walk at 12 months | 63.2 |
| Walk with aid at 12months | 35.7 |
| Unable to walk at 12 months | 1.2 |
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).
| units on a scale | Balloon Kyphoplasty |
|---|---|
| Barthel index score at baseline | 16.2 ± 4.0 |
| Barthel index score at 30 days | 18.8 ± 2.1 |
| Barthel index score at 3 months | 19.1 ± 2.0 |
| Barthel index score at 6 months | 19.1 ± 1.8 |
| Barthel index score at 12 months | 19.1 ± 1.8 |
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.
| units on a scale | Balloon Kyphoplasty |
|---|---|
| Karnofsky performance scale at baseline | 75.7 ± 21.5 |
| Karnofsky performance scale at 30 days | 88.0 ± 11.0 |
| Karnofsky performance scale at 3 months | 90.0 ± 14.1 |
| Karnofsky performance scale at 6 months | 85.0 ± 30.0 |
| Karnofsky performance scale at 12 months | 96.7 ± 5.8 |
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.
| percentage of pre-fracture height | Balloon Kyphoplasty |
|---|---|
| Anterior height Loss from EP at baseline | -26.438 ± 22.008 |
| Middle height loss from EP at baseline | -27.719 ± 20.861 |
| Posterior height loss from EP at baseline | -8.228 ± 10.966 |
| Anterior AHRP at pre-discharge | 3.897 ± 9.822 |
| Middle AHRP at pre-discharge | 4.205 ± 9.783 |
| Posterior AHRP at pre-discharge | 1.280 ± 7.280 |
| Anterior AHRP at 3 months | 1.511 ± 10.426 |
| Middle AHRP at 3 months | 2.223 ± 10.076 |
| Posterior AHRP at 3 months | 0.101 ± 7.474 |
| Anterior AHRP at 12 months | 1.308 ± 10.765 |
| Middle AHRP at 12 months | 1.567 ± 10.453 |
| Posterior AHRP at 12 months | -0.028 ± 8.284 |
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.
| degrees | Balloon Kyphoplasty |
|---|---|
| vertebral body angle at baseline | -10.474 ± 8.152 |
| Vertebral body angle at pre-discharge | -9.522 ± 6.867 |
| Angle change from baseline at pre-discharge | 1.117 ± 4.137 |
| Vertebral body angle at 3 months | -10.119 ± 6.781 |
| Angle change from baseline at 3 months | 0.633 ± 4.282 |
| Vertebral body angle at 12 months | -9.876 ± 6.714 |
| Angle change from baseline at 12 months | 0.748 ± 4.315 |
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.
| degrees | Balloon Kyphoplasty |
|---|---|
| Local Cobb angle at baseline | -12.919 ± 18.302 |
| Local Cobb angle at pre-discharge | -11.190 ± 17.244 |
| Angle change from baseline at pre-discharge | 2.707 ± 5.102 |
| Local Cobb angle at 3 months | -13.439 ± 17.843 |
| Angle change from baseline at 3 months | 0.253 ± 5.979 |
| Local Cobb angle at 12 months | -12.819 ± 18.643 |
| Angle change from baseline at 12 months | -0.197 ± 6.106 |
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.
| percentage of participants | Balloon Kyphoplasty |
|---|---|
| Subsequent fractures at 3 months | 36.7 |
| Subsequent fractures at 12 months | 47.6 |
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.
| percentage of participants | Balloon Kyphoplasty |
|---|---|
| Neurological success at predischarge | 79.2 |
| Neurological success at 30 days | 76.7 |
| Neurological success at 3 months | 76.4 |
| Neurological success at 6 months | 74.3 |
| Neurological success at 12 months | 76.7 |
Collected over Overall study about 12-month follow up. Non-serious events are listed at a 0.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Balloon Kyphoplasty | — | 79/350 (22.6%) | 128/350 (36.6%) |
| Event | Balloon Kyphoplasty |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 17/350 |
| Spinal compression fractureInjury, poisoning and procedural complications | 11/350 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 5/350 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/350 |
| PneumoniaInfections and infestations | 3/350 |
| FallInjury, poisoning and procedural complications | 3/350 |
| Cardiac arrestCardiac disorders | 2/350 |
| CholelithiasisHepatobiliary disorders | 2/350 |
| Hip fractureInjury, poisoning and procedural complications | 2/350 |
| Lumbar vertebral fractureInjury, poisoning and procedural complications | 2/350 |
| Event | Balloon Kyphoplasty |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 27/350 |
| Spinal compression fractureInjury, poisoning and procedural complications | 18/350 |
| ArthritisMusculoskeletal and connective tissue disorders | 11/350 |
| KyphosisMusculoskeletal and connective tissue disorders | 10/350 |
| FallInjury, poisoning and procedural complications | 9/350 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/350 |
| SacroiliitisMusculoskeletal and connective tissue disorders | 6/350 |
| Rib fractureInjury, poisoning and procedural complications | 4/350 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 4/350 |
| BursitisMusculoskeletal and connective tissue disorders | 4/350 |
| Age, Continuous(years) | Balloon Kyphoplasty |
|---|---|
| Mean | 78.9 ± 8.1 |
| Sex: Female, Male(Participants) | Balloon Kyphoplasty |
|---|---|
| Female | 272 |
| Male | 78 |
| Ethnicity (NIH/OMB)(Participants) | Balloon Kyphoplasty |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 344 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Balloon Kyphoplasty |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 12 |
| Black or African American | 4 |
| Native Hawaiian or other pacific islander | 0 |
| White | 330 |
| Other | 3 |
| Height(inches) | Balloon Kyphoplasty |
|---|---|
| Mean | 64.3 ± 3.9 |
| Weight(lbs) | Balloon Kyphoplasty |
|---|---|
| Mean | 153.9 ± 36.9 |
| BMI(kg/m^2) | Balloon Kyphoplasty |
|---|---|
| Mean | 26.1 ± 5.5 |
| Estimated pre-fracture vertebral body height(mm) | Balloon Kyphoplasty |
|---|---|
| Anterior | 24.940 ± 4.811 |
| Middle | 24.207 ± 4.264 |
| Posterior | 26.502 ± 4.397 |
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Medtronic Spinal and Biologics