Trial Outcomes & Findings for Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs (NCT NCT01871519)
NCT ID: NCT01871519
Last Updated: 2017-03-29
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
354 participants
Primary outcome timeframe
Baseline, 3 months after surgery
Results posted on
2017-03-29
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
350
|
|
Overall Study
COMPLETED
|
260
|
|
Overall Study
NOT COMPLETED
|
90
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
26
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Withdrawal by Subject
|
49
|
Baseline Characteristics
A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.
Baseline characteristics by cohort
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Age, Continuous
|
78.9 years
STANDARD_DEVIATION 8.1 • n=350 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=350 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=350 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=350 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
344 Participants
n=350 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
White
|
330 Participants
n=350 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=350 Participants
|
|
Height
|
64.3 inches
STANDARD_DEVIATION 3.9 • n=350 Participants
|
|
Weight
|
153.9 lbs
STANDARD_DEVIATION 36.9 • n=350 Participants
|
|
BMI
|
26.1 kg/m^2
STANDARD_DEVIATION 5.5 • n=350 Participants
|
|
Estimated pre-fracture vertebral body height
Anterior
|
24.940 mm
STANDARD_DEVIATION 4.811 • n=344 Participants • A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.
|
|
Estimated pre-fracture vertebral body height
Middle
|
24.207 mm
STANDARD_DEVIATION 4.264 • n=344 Participants • A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.
|
|
Estimated pre-fracture vertebral body height
Posterior
|
26.502 mm
STANDARD_DEVIATION 4.397 • n=344 Participants • A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.
|
PRIMARY outcome
Timeframe: Baseline, 3 months after surgeryPopulation: 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.
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."
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Back Pain Change From Baseline at 3 Months
Back pain at baseline
|
8.7 units on a scale
Standard Deviation 1.2
|
|
Back Pain Change From Baseline at 3 Months
Back pain at 3 Months
|
2.7 units on a scale
Standard Deviation 2.7
|
|
Back Pain Change From Baseline at 3 Months
Back pain change
|
-6.0 units on a scale
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Baseline, 3 months after surgeryPopulation: 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.
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).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, 3 months after surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=346 Participants
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.
|
|---|---|
|
SF-36v2 Physical Component Summary Change From Baseline at 3 Months
SF-36 PCS at baseline
|
24.2 units on a scale
Standard Deviation 7.0
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline, 3 months after surgeryPopulation: 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.
EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=348 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, 7 days, 30 days, 6 months, 9 months, and 12 monthsPopulation: 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.
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."
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Back Pain
Back pain at baseline
|
8.7 units on a scale
Standard Deviation 1.2
|
|
Back Pain
Back pain at 7 days
|
3.4 units on a scale
Standard Deviation 2.3
|
|
Back Pain
Back pain at 30 days
|
3.2 units on a scale
Standard Deviation 2.7
|
|
Back Pain
Back pain at 6 months
|
2.5 units on a scale
Standard Deviation 2.7
|
|
Back Pain
Back pain at 9 months
|
2.3 units on a scale
Standard Deviation 2.6
|
|
Back Pain
Back pain at 12 months
|
2.4 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 6 months, and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Back Function (ODI)
ODI score at baseline
|
63.4 units on a scale
Standard Deviation 14.9
|
|
Back Function (ODI)
ODI score at 30 days
|
32.5 units on a scale
Standard Deviation 19.5
|
|
Back Function (ODI)
ODI score at 6 months
|
25.7 units on a scale
Standard Deviation 19.0
|
|
Back Function (ODI)
ODI score at 12 months
|
25.8 units on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 6 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=346 Participants
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.
|
|---|---|
|
Quality of Life by SF-36v2 PCS
SF-36 PCS at baseline
|
24.2 units on a scale
Standard Deviation 7.0
|
|
Quality of Life by SF-36v2 PCS
SF-36 PCS at 30 days
|
34.9 units on a scale
Standard Deviation 9.8
|
|
Quality of Life by SF-36v2 PCS
SF-36 PCS at 6 months
|
37.6 units on a scale
Standard Deviation 11.5
|
|
Quality of Life by SF-36v2 PCS
SF-36 PCS at 12 months
|
38.2 units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 6 months, and 12 monthsPopulation: 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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=348 Participants
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.
|
|---|---|
|
Quality of Life by EQ-5D Index Score
EQ-5D index at baseline
|
0.383 units on a scale
Standard Deviation 0.212
|
|
Quality of Life by EQ-5D Index Score
EQ-5D index at 30 days
|
0.710 units on a scale
Standard Deviation 0.196
|
|
Quality of Life by EQ-5D Index Score
EQ-5D index at 6 months
|
0.756 units on a scale
Standard Deviation 0.193
|
|
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 outcome
Timeframe: Baseline, 30 days, 3 months, 6 months, and 12 monthsPopulation: 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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
Baseline
|
96.3 percentage of participants
|
|
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
30 days
|
53.3 percentage of participants
|
|
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
3 months
|
31.8 percentage of participants
|
|
Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
6 months
|
31.0 percentage of participants
|
|
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 outcome
Timeframe: Baseline, 30 days, 3 months, 6 months, and 12 monthsPopulation: 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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 monthsPopulation: 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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Ambulatory Status
Unable to walk at 7 days
|
1.8 percentage of participants
|
|
Ambulatory Status
Able to walk at 30 days
|
62.5 percentage of participants
|
|
Ambulatory Status
Walk with aid at 30 days
|
36.2 percentage of participants
|
|
Ambulatory Status
Unable to walk at 30 days
|
1.3 percentage of participants
|
|
Ambulatory Status
Able to walk at 3 months
|
64.5 percentage of participants
|
|
Ambulatory Status
Walk with aid at 3 months
|
34.1 percentage of participants
|
|
Ambulatory Status
Able to walk at 12 months
|
63.2 percentage of participants
|
|
Ambulatory Status
Able to walk at baseline
|
42.3 percentage of participants
|
|
Ambulatory Status
Walk with aid at baseline
|
50.3 percentage of participants
|
|
Ambulatory Status
Unable to walk at baseline
|
7.4 percentage of participants
|
|
Ambulatory Status
Able to walk at 7 days
|
59.9 percentage of participants
|
|
Ambulatory Status
Walk with aid at 7 days
|
38.3 percentage of participants
|
|
Ambulatory Status
Unable to walk at 3 months
|
1.4 percentage of participants
|
|
Ambulatory Status
Able to walk at 6 months
|
62.4 percentage of participants
|
|
Ambulatory Status
Walk with aid at 6 months
|
36.1 percentage of participants
|
|
Ambulatory Status
Unable to walk at 6 months
|
1.5 percentage of participants
|
|
Ambulatory Status
Able to walk at 9 months
|
68.7 percentage of participants
|
|
Ambulatory Status
Walk with aid at 9 months
|
30.9 percentage of participants
|
|
Ambulatory Status
Unable to walk at 9 months
|
0.4 percentage of participants
|
|
Ambulatory Status
Walk with aid at 12months
|
35.7 percentage of participants
|
|
Ambulatory Status
Unable to walk at 12 months
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 3 months 6 months, and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=343 Participants
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.
|
|---|---|
|
Barthel Index (Only for Subjects With Osteoporosis)
Barthel index score at 3 months
|
19.1 units on a scale
Standard Deviation 2.0
|
|
Barthel Index (Only for Subjects With Osteoporosis)
Barthel index score at 6 months
|
19.1 units on a scale
Standard Deviation 1.8
|
|
Barthel Index (Only for Subjects With Osteoporosis)
Barthel index score at 12 months
|
19.1 units on a scale
Standard Deviation 1.8
|
|
Barthel Index (Only for Subjects With Osteoporosis)
Barthel index score at baseline
|
16.2 units on a scale
Standard Deviation 4.0
|
|
Barthel Index (Only for Subjects With Osteoporosis)
Barthel index score at 30 days
|
18.8 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 3 months 6 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=7 Participants
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.
|
|---|---|
|
Karnofsky Performance Scale
Karnofsky performance scale at baseline
|
75.7 units on a scale
Standard Deviation 21.5
|
|
Karnofsky Performance Scale
Karnofsky performance scale at 30 days
|
88.0 units on a scale
Standard Deviation 11.0
|
|
Karnofsky Performance Scale
Karnofsky performance scale at 3 months
|
90.0 units on a scale
Standard Deviation 14.1
|
|
Karnofsky Performance Scale
Karnofsky performance scale at 6 months
|
85.0 units on a scale
Standard Deviation 30.0
|
|
Karnofsky Performance Scale
Karnofsky performance scale at 12 months
|
96.7 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline, pre-discharge, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=490 Treated levels
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)
Posterior AHRP at pre-discharge
|
1.280 percentage of pre-fracture height
Standard Deviation 7.280
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, pre-discharge, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=490 Treated levels
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.
|
|---|---|
|
Vertebral Body Angle
Vertebral body angle at 3 months
|
-10.119 degrees
Standard Deviation 6.781
|
|
Vertebral Body Angle
Angle change from baseline at 3 months
|
0.633 degrees
Standard Deviation 4.282
|
|
Vertebral Body Angle
Vertebral body angle at 12 months
|
-9.876 degrees
Standard Deviation 6.714
|
|
Vertebral Body Angle
vertebral body angle at baseline
|
-10.474 degrees
Standard Deviation 8.152
|
|
Vertebral Body Angle
Vertebral body angle at pre-discharge
|
-9.522 degrees
Standard Deviation 6.867
|
|
Vertebral Body Angle
Angle change from baseline at pre-discharge
|
1.117 degrees
Standard Deviation 4.137
|
|
Vertebral Body Angle
Angle change from baseline at 12 months
|
0.748 degrees
Standard Deviation 4.315
|
SECONDARY outcome
Timeframe: Baseline, pre-discharge, 3 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=490 Treated levels
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.
|
|---|---|
|
Local Cobb Angle
Local Cobb angle at baseline
|
-12.919 degrees
Standard Deviation 18.302
|
|
Local Cobb Angle
Local Cobb angle at pre-discharge
|
-11.190 degrees
Standard Deviation 17.244
|
|
Local Cobb Angle
Angle change from baseline at pre-discharge
|
2.707 degrees
Standard Deviation 5.102
|
|
Local Cobb Angle
Local Cobb angle at 3 months
|
-13.439 degrees
Standard Deviation 17.843
|
|
Local Cobb Angle
Angle change from baseline at 3 months
|
0.253 degrees
Standard Deviation 5.979
|
|
Local Cobb Angle
Local Cobb angle at 12 months
|
-12.819 degrees
Standard Deviation 18.643
|
|
Local Cobb Angle
Angle change from baseline at 12 months
|
-0.197 degrees
Standard Deviation 6.106
|
SECONDARY outcome
Timeframe: 3 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=267 Participants
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.
|
|---|---|
|
Subsequent Radiographic Fractures
Subsequent fractures at 3 months
|
36.7 percentage of participants
|
|
Subsequent Radiographic Fractures
Subsequent fractures at 12 months
|
47.6 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-discharge, 30 days, 3 months, 6 months, and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=350 Participants
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.
|
|---|---|
|
Neurological Success Rate
Neurological success at predischarge
|
79.2 percentage of participants
|
|
Neurological Success Rate
Neurological success at 30 days
|
76.7 percentage of participants
|
|
Neurological Success Rate
Neurological success at 3 months
|
76.4 percentage of participants
|
|
Neurological Success Rate
Neurological success at 6 months
|
74.3 percentage of participants
|
|
Neurological Success Rate
Neurological success at 12 months
|
76.7 percentage of participants
|
Adverse Events
Balloon Kyphoplasty
Serious events: 79 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balloon Kyphoplasty
n=350 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Cardiac arrest
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Coronary artery disease
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Tachycardia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Eye disorders
Cataract
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
General physical health deterioration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Hepatobiliary disorders
Lupus hepatitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Cellulitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Pneumonia
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Fall
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.57%
2/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
3.1%
11/350 • Number of events 14 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
17/350 • Number of events 26 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Hydrocephalus
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Sciatica
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Transient ischaemic attack
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Renal and urinary disorders
Haematuria
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Renal and urinary disorders
Renal failure
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Renal and urinary disorders
Renal failure chronic
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
5/350 • Number of events 7 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
4/350 • Number of events 4 • Overall study about 12-month follow up
|
|
Vascular disorders
Vascular stenosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
Other adverse events
| Measure |
Balloon Kyphoplasty
n=350 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Atrial fibrillation
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Cardiac disorders
Atrioventricular block
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Cardiac disorders
Tachyarrhythmia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Ear and labyrinth disorders
Vertigo
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Coeliac disease
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Constipation
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Death
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Device breakage
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Device malfunction
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Implant site extravasation
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Oedema peripheral
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
General disorders
Pain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Bronchitis
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Infections and infestations
Cystitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Herpes zoster
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Infections and infestations
Kidney infection
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Pneumonia
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Infections and infestations
Upper respiratory tract infection
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Contusion
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
9/350 • Number of events 9 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Laceration
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
4/350 • Number of events 4 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.1%
18/350 • Number of events 18 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.1%
4/350 • Number of events 4 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
8/350 • Number of events 8 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
11/350 • Number of events 11 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
27/350 • Number of events 30 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
4/350 • Number of events 5 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
2.9%
10/350 • Number of events 10 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
1.7%
6/350 • Number of events 6 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.1%
4/350 • Number of events 4 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.1%
4/350 • Number of events 4 • Overall study about 12-month follow up
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Balance disorder
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Convulsion
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Dizziness
|
0.86%
3/350 • Number of events 3 • Overall study about 12-month follow up
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Headache
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Nervous system disorders
Hypoaesthesia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Neuropathy peripheral
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Radiculitis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Radiculopathy
|
0.57%
2/350 • Number of events 2 • Overall study about 12-month follow up
|
|
Nervous system disorders
Spinal cord compression
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Syncope
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Psychiatric disorders
Insomnia
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Psychiatric disorders
Mental status changes
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Renal and urinary disorders
Renal failure
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Renal and urinary disorders
Urinary incontinence
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Vascular disorders
Haematoma
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Vascular disorders
Hypertensive crisis
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
|
Vascular disorders
Labile hypertension
|
0.29%
1/350 • Number of events 1 • Overall study about 12-month follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60