Trial Outcomes & Findings for CAFE Study - Cancer Patient Fracture Evaluation (NCT NCT00211237)
NCT ID: NCT00211237
Last Updated: 2021-01-05
Results Overview
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Baseline and 1 Month
Results posted on
2021-01-05
Participant Flow
Of 134 enrolled subjects, 70 were randomized to Balloon Kyphoplasty and 64 to non-surgical management (NSM). Two of the subjects who were randomized to Balloon Kyphoplasty and 3 of the subjects who were randomized to NSM were excluded from the mITT and PP Populations, because they terminated in a few days of enrolment and had no treatment.
Crossover from the NSM group to Balloon Kyphoplasty group was permitted after completion of the 1-month evaluation.
Participant milestones
| Measure |
Balloon Kyphoplasty
The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non-surgical Management
The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|
|
Baseline
STARTED
|
70
|
64
|
0
|
|
Baseline
COMPLETED
|
68
|
61
|
0
|
|
Baseline
NOT COMPLETED
|
2
|
3
|
0
|
|
1 Month
STARTED
|
68
|
61
|
0
|
|
1 Month
COMPLETED
|
65
|
52
|
0
|
|
1 Month
NOT COMPLETED
|
3
|
9
|
0
|
|
3 Months
STARTED
|
65
|
18
|
34
|
|
3 Months
COMPLETED
|
57
|
14
|
33
|
|
3 Months
NOT COMPLETED
|
8
|
4
|
1
|
|
6 Months
STARTED
|
57
|
11
|
36
|
|
6 Months
COMPLETED
|
49
|
9
|
33
|
|
6 Months
NOT COMPLETED
|
8
|
2
|
3
|
|
12 Months
STARTED
|
49
|
8
|
34
|
|
12 Months
COMPLETED
|
40
|
6
|
28
|
|
12 Months
NOT COMPLETED
|
9
|
2
|
6
|
Reasons for withdrawal
| Measure |
Balloon Kyphoplasty
The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non-surgical Management
The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|
|
Baseline
Withdrew
|
1
|
3
|
0
|
|
Baseline
Refused random assignment
|
1
|
0
|
0
|
|
1 Month
Death
|
2
|
1
|
0
|
|
1 Month
Lost to Follow-up
|
0
|
2
|
0
|
|
1 Month
Withdrew
|
0
|
4
|
0
|
|
1 Month
Additional surgery needed
|
1
|
0
|
0
|
|
1 Month
Non-medical problem
|
0
|
2
|
0
|
|
3 Months
Death
|
7
|
3
|
0
|
|
3 Months
Could not comply with protocol
|
1
|
0
|
0
|
|
3 Months
Withdrew
|
0
|
1
|
0
|
|
3 Months
Non-medical problem
|
0
|
0
|
1
|
|
6 Months
Death
|
6
|
0
|
3
|
|
6 Months
Lost to Follow-up
|
2
|
0
|
0
|
|
6 Months
Could not comply with protocol
|
0
|
2
|
0
|
|
12 Months
Death
|
8
|
2
|
3
|
|
12 Months
Lost to Follow-up
|
1
|
0
|
1
|
|
12 Months
Withdrew
|
0
|
0
|
1
|
|
12 Months
unrelated medical problem
|
0
|
0
|
1
|
Baseline Characteristics
CAFE Study - Cancer Patient Fracture Evaluation
Baseline characteristics by cohort
| Measure |
Balloon Kyphoplasty
n=70 Participants
The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=64 Participants
The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
40 participants
n=5 Participants
|
35 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 MonthPopulation: The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.
The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
Outcome measures
| Measure |
Balloon Kyphoplasty
n=63 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=50 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
Baseline
|
17.6 score on a scale
Interval 16.6 to 18.5
|
18.2 score on a scale
Interval 17.4 to 19.0
|
—
|
—
|
|
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
Change from baseline to one month
|
-8.3 score on a scale
Interval -10.2 to -6.4
|
0.1 score on a scale
Interval -0.8 to 1.0
|
—
|
—
|
|
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
One month
|
9.1 score on a scale
Interval 7.4 to 10.9
|
18.0 score on a scale
Interval 16.9 to 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Roland-Morris Disability Questionnaire Score
RMDQ score at baseline
|
17.6 units on a scale
Standard Deviation 3.9
|
17.9 units on a scale
Standard Deviation 4.2
|
18.3 units on a scale
Standard Deviation 2.6
|
—
|
|
Change in Roland-Morris Disability Questionnaire Score
Change from baseline to 1 months
|
-8.3 units on a scale
Standard Deviation 7.6
|
0.3 units on a scale
Standard Deviation 3.1
|
-7.3 units on a scale
Standard Deviation 6.8
|
—
|
|
Change in Roland-Morris Disability Questionnaire Score
Change from baseline to 3 months
|
-8.9 units on a scale
Standard Deviation 7.0
|
-2.7 units on a scale
Standard Deviation 6.1
|
-10.2 units on a scale
Standard Deviation 6.1
|
—
|
|
Change in Roland-Morris Disability Questionnaire Score
Change from baseline to 6 months
|
-8.2 units on a scale
Standard Deviation 6.0
|
-3.6 units on a scale
Standard Deviation 9.4
|
-10.8 units on a scale
Standard Deviation 6.1
|
—
|
|
Change in Roland-Morris Disability Questionnaire Score
Change from baseline to 12 months
|
-9.7 units on a scale
Standard Deviation 6.4
|
-4.5 units on a scale
Standard Deviation 11.4
|
-10.4 units on a scale
Standard Deviation 6.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Change from baseline to one month
|
15.9 units on a scale
Standard Deviation 21.2
|
0.6 units on a scale
Standard Deviation 11.6
|
—
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Baseline score
|
57.1 units on a scale
Standard Deviation 18.0
|
57.3 units on a scale
Standard Deviation 15.8
|
—
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Score at 1 month
|
73.2 units on a scale
Standard Deviation 15.5
|
58.6 units on a scale
Standard Deviation 16.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Baseline score
|
57.1 units on a scale
Standard Deviation 18.0
|
55.0 units on a scale
Standard Deviation 17.7
|
58.7 units on a scale
Standard Deviation 14.6
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Change from baseline to 1 month
|
15.9 units on a scale
Standard Deviation 21.2
|
0.0 units on a scale
Standard Deviation 14.1
|
19.2 units on a scale
Standard Deviation 20.6
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Change from baseline to 3 months
|
18.0 units on a scale
Standard Deviation 23.8
|
10.0 units on a scale
Standard Deviation 16.3
|
21.1 units on a scale
Standard Deviation 19.1
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Change from baseline to 6 months
|
18.0 units on a scale
Standard Deviation 23.1
|
12.5 units on a scale
Standard Deviation 21.2
|
23.3 units on a scale
Standard Deviation 19.8
|
—
|
|
Change in Functional Status Assessed With the Karnofsky Performance Scale
Change from baseline to 12 months
|
23.0 units on a scale
Standard Deviation 25.2
|
21.7 units on a scale
Standard Deviation 23.2
|
22.2 units on a scale
Standard Deviation 18.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Back Pain
Baseline
|
7.3 units on a scale
Standard Deviation 1.6
|
7.3 units on a scale
Standard Deviation 1.4
|
—
|
—
|
|
Change in Back Pain
1 month
|
3.3 units on a scale
Standard Deviation 2.8
|
6.9 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Change in Back Pain
Change from baseline to 1 month
|
-3.9 units on a scale
Standard Deviation 3.2
|
-0.6 units on a scale
Standard Deviation 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Back Pain
Change from baseline to 7 days
|
-3.8 units on a scale
Standard Deviation 3.0
|
-0.7 units on a scale
Standard Deviation 1.8
|
-4.0 units on a scale
Standard Deviation 3.1
|
—
|
|
Change in Back Pain
Change from baseline to 1 month
|
-3.9 units on a scale
Standard Deviation 3.2
|
-0.9 units on a scale
Standard Deviation 2.0
|
-4.1 units on a scale
Standard Deviation 2.9
|
—
|
|
Change in Back Pain
Back pain at baseline
|
7.3 units on a scale
Standard Deviation 1.6
|
6.8 units on a scale
Standard Deviation 1.5
|
7.6 units on a scale
Standard Deviation 1.4
|
—
|
|
Change in Back Pain
Change from baseline to 3 months
|
-3.6 units on a scale
Standard Deviation 3.3
|
-2.1 units on a scale
Standard Deviation 2.1
|
-4.3 units on a scale
Standard Deviation 2.8
|
—
|
|
Change in Back Pain
Change from baseline to 6 months
|
-3.7 units on a scale
Standard Deviation 3.2
|
-2.4 units on a scale
Standard Deviation 3.9
|
-4.8 units on a scale
Standard Deviation 2.9
|
—
|
|
Change in Back Pain
Change from baseline to 12 months
|
-3.9 units on a scale
Standard Deviation 3.2
|
-3.0 units on a scale
Standard Deviation 3.2
|
-4.9 units on a scale
Standard Deviation 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Quality of Life.
PCS change from baseline to 1 month
|
9.4 units on a scale
Standard Deviation 9.4
|
1.0 units on a scale
Standard Deviation 6.0
|
—
|
—
|
|
Change in Quality of Life.
MCS change from baseline to 1 month
|
9.2 units on a scale
Standard Deviation 14.6
|
-1.9 units on a scale
Standard Deviation 12.7
|
—
|
—
|
|
Change in Quality of Life.
SF-36 PCS at baseline
|
25.4 units on a scale
Standard Deviation 6.0
|
24.8 units on a scale
Standard Deviation 6.4
|
—
|
—
|
|
Change in Quality of Life.
SF-36 PCS at 1 month
|
35.2 units on a scale
Standard Deviation 10.1
|
26.0 units on a scale
Standard Deviation 6.3
|
—
|
—
|
|
Change in Quality of Life.
SF-36 MCS at baseline
|
38.2 units on a scale
Standard Deviation 13.3
|
37.3 units on a scale
Standard Deviation 13.4
|
—
|
—
|
|
Change in Quality of Life.
SF-36 MCS at 1 month
|
46.4 units on a scale
Standard Deviation 13.0
|
36.1 units on a scale
Standard Deviation 13.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Quality of Life
MCS change from baseline to 1 month
|
9.2 units on a scale
Standard Deviation 14.6
|
-1.1 units on a scale
Standard Deviation 12.4
|
6.8 units on a scale
Standard Deviation 15.9
|
—
|
|
Change in Quality of Life
SF-36 PCS at baseline
|
25.4 units on a scale
Standard Deviation 6.0
|
25.3 units on a scale
Standard Deviation 4.8
|
24.5 units on a scale
Standard Deviation 7.2
|
—
|
|
Change in Quality of Life
PCS change from baseline to 1 months
|
9.4 units on a scale
Standard Deviation 9.4
|
-0.2 units on a scale
Standard Deviation 4.2
|
9.1 units on a scale
Standard Deviation 9.5
|
—
|
|
Change in Quality of Life
PCS change from baseline to 3 months
|
10.0 units on a scale
Standard Deviation 11.1
|
1.1 units on a scale
Standard Deviation 6.4
|
11.1 units on a scale
Standard Deviation 9.3
|
—
|
|
Change in Quality of Life
PCS change from baseline to 6 months
|
9.1 units on a scale
Standard Deviation 9.1
|
-0.8 units on a scale
Standard Deviation 6.2
|
10.8 units on a scale
Standard Deviation 9.2
|
—
|
|
Change in Quality of Life
PCS change from baseline to 12 months
|
11.7 units on a scale
Standard Deviation 10.3
|
1.3 units on a scale
Standard Deviation 9.1
|
11.9 units on a scale
Standard Deviation 7.9
|
—
|
|
Change in Quality of Life
SF-36 MCS at baseline
|
38.2 units on a scale
Standard Deviation 13.3
|
36.0 units on a scale
Standard Deviation 14.7
|
38.1 units on a scale
Standard Deviation 12.7
|
—
|
|
Change in Quality of Life
MCS change from baseline to 3 months
|
7.6 units on a scale
Standard Deviation 15.0
|
7.3 units on a scale
Standard Deviation 13.4
|
9.2 units on a scale
Standard Deviation 17.0
|
—
|
|
Change in Quality of Life
MCS change from baseline to 6 months
|
8.5 units on a scale
Standard Deviation 15.2
|
4.3 units on a scale
Standard Deviation 12.1
|
13.1 units on a scale
Standard Deviation 15.5
|
—
|
|
Change in Quality of Life
MCS change from baseline to 12 months
|
7.8 units on a scale
Standard Deviation 15.5
|
5.6 units on a scale
Standard Deviation 12.5
|
9.2 units on a scale
Standard Deviation 17.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at 1 month
|
38 percentage of participants
|
6.6 percentage of participants
|
—
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at baseline
|
90 percentage of participants
|
97 percentage of participants
|
—
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at baseline
|
8.8 percentage of participants
|
1.6 percentage of participants
|
—
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't known at baseline
|
1.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at 1 month
|
56 percentage of participants
|
75 percentage of participants
|
—
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't know at 1 month
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at baseline
|
8.8 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at 3 months
|
43 percentage of participants
|
4.3 percentage of participants
|
58 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't know at 3 months
|
0 percentage of participants
|
0.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't know at 6 months
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at 12 months
|
19 percentage of participants
|
17 percentage of participants
|
39 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't know at 12 months
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't known at baseline
|
1.5 percentage of participants
|
0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at baseline
|
90 percentage of participants
|
96 percentage of participants
|
97 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at 1 month
|
56 percentage of participants
|
48 percentage of participants
|
53 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at 1 month
|
38 percentage of participants
|
4.3 percentage of participants
|
47 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Don't know at 1 month
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at 3 months
|
37 percentage of participants
|
39 percentage of participants
|
34 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
Activities reduced at 6 months
|
34 percentage of participants
|
26 percentage of participants
|
32 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at 6 months
|
38 percentage of participants
|
8.7 percentage of participants
|
55 percentage of participants
|
—
|
|
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
No activities reduced at 12 months
|
40 percentage of participants
|
8.7 percentage of participants
|
32 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Baseline
|
10.8 days
Standard Deviation 4.9
|
11.5 days
Standard Deviation 4.3
|
—
|
—
|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Change from baseline to one month
|
-5.2 days
Standard Deviation 7.1
|
1.1 days
Standard Deviation 4.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Change from baseline to 6 months
|
-5.0 days
Standard Deviation 7.9
|
-2.9 days
Standard Deviation 7.9
|
-8.5 days
Standard Deviation 5.2
|
—
|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Baseline
|
10.8 days
Standard Deviation 4.9
|
12.0 days
Standard Deviation 3.6
|
11.0 days
Standard Deviation 4.8
|
—
|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Change from baseline to 1 months
|
-5.2 days
Standard Deviation 7.1
|
-0.4 days
Standard Deviation 3.3
|
-5.6 days
Standard Deviation 7.2
|
—
|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Change from baseline to 3 months
|
-5.5 days
Standard Deviation 7.0
|
-1.8 days
Standard Deviation 6.3
|
-7.4 days
Standard Deviation 7.1
|
—
|
|
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
Change from baseline to 12 months
|
-7.8 days
Standard Deviation 6.4
|
-5.2 days
Standard Deviation 5.2
|
-7.4 days
Standard Deviation 7.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Change from baseline to 1 month
|
-4.0 days
Standard Deviation 7.7
|
0.2 days
Standard Deviation 4.7
|
—
|
—
|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Baseline
|
6.3 days
Standard Deviation 6.3
|
6.8 days
Standard Deviation 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Change from baseline to 1 month
|
-4.0 days
Standard Deviation 7.7
|
-0.2 days
Standard Deviation 5.9
|
-4.5 days
Standard Deviation 6.0
|
—
|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Baseline
|
6.3 days
Standard Deviation 6.3
|
8.1 days
Standard Deviation 5.9
|
5.8 days
Standard Deviation 6.0
|
—
|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Change from baseline to 3 months
|
-3.4 days
Standard Deviation 7.7
|
-4.8 days
Standard Deviation 6.0
|
-5.0 days
Standard Deviation 6.1
|
—
|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Change from baseline to 6 months
|
-3.8 days
Standard Deviation 7.6
|
-4.1 days
Standard Deviation 7.8
|
-5.7 days
Standard Deviation 5.9
|
—
|
|
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
Change from baseline to 12 months
|
-5.8 days
Standard Deviation 6.3
|
-4.3 days
Standard Deviation 6.2
|
-4.7 days
Standard Deviation 6.8
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Ambulatory Status Change From Baseline to One Month
No change in ambulatory status at 1 month
|
74 percentage of participants
|
66 percentage of participants
|
—
|
—
|
|
Ambulatory Status Change From Baseline to One Month
Fully ambulatory at baseline
|
56 percentage of participants
|
56 percentage of participants
|
—
|
—
|
|
Ambulatory Status Change From Baseline to One Month
Assisted ambulatory
|
32 percentage of participants
|
34 percentage of participants
|
—
|
—
|
|
Ambulatory Status Change From Baseline to One Month
Not ambulatory
|
10 percentage of participants
|
8.2 percentage of participants
|
—
|
—
|
|
Ambulatory Status Change From Baseline to One Month
Ambulatory status improved at 1 month
|
16 percentage of participants
|
6.6 percentage of participants
|
—
|
—
|
|
Ambulatory Status Change From Baseline to One Month
Ambulatory status worsened at 1 month
|
2.9 percentage of participants
|
9.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Ambulatory Status Change
Assisted ambulatory at baseline
|
32 percentage of participants
|
30 percentage of participants
|
39 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status improved at 6 months
|
10 percentage of participants
|
4.3 percentage of participants
|
16 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status worsened at 6 months
|
5.9 percentage of participants
|
4.3 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status improved at 12 months
|
12 percentage of participants
|
4.3 percentage of participants
|
16 percentage of participants
|
—
|
|
Ambulatory Status Change
Full ambulatory at baseline
|
56 percentage of participants
|
57 percentage of participants
|
55 percentage of participants
|
—
|
|
Ambulatory Status Change
Not ambulatory at baseline
|
10 percentage of participants
|
13 percentage of participants
|
5.3 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status improved at 7 days
|
10 percentage of participants
|
0 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status no change at 7 days
|
79 percentage of participants
|
70 percentage of participants
|
87 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status worsened at 7 days
|
2.9 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status improved at 1 month
|
16 percentage of participants
|
0 percentage of participants
|
11 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status no change at 1 month
|
74 percentage of participants
|
39 percentage of participants
|
87 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status worsened at 1 month
|
2.9 percentage of participants
|
13 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status improved at 3 months
|
18 percentage of participants
|
4.3 percentage of participants
|
16 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status no change at 3 months
|
53 percentage of participants
|
35 percentage of participants
|
76 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status worsened at 3 months
|
8.8 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status no change at 6 months
|
54 percentage of participants
|
26 percentage of participants
|
63 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status no change at 12 months
|
41 percentage of participants
|
17 percentage of participants
|
53 percentage of participants
|
—
|
|
Ambulatory Status Change
Ambulatory status worsened at 12 months
|
4.4 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Lumbar cobb angle change at 1 month
|
0.626 degrees
Standard Deviation 7.075
|
2.883 degrees
Standard Deviation 7.634
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Local Cobb angel of T5-L1 at baseline
|
22.914 degrees
Standard Deviation 12.720
|
22.792 degrees
Standard Deviation 15.191
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Local cobb angle of L2-L4 at baseline
|
-7.715 degrees
Standard Deviation 15.470
|
-8.291 degrees
Standard Deviation 14.662
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Kyphotic angle at baseline
|
9.523 degrees
Standard Deviation 8.751
|
10.501 degrees
Standard Deviation 8.833
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Kyphotic angle change at 1 month
|
0.135 degrees
Standard Deviation 5.088
|
-0.598 degrees
Standard Deviation 3.442
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Thoracic cobb angle at baseline
|
50.976 degrees
Standard Deviation 17.316
|
51.390 degrees
Standard Deviation 19.621
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Thoracic cobb angle change to one month
|
0.666 degrees
Standard Deviation 9.253
|
-0.012 degrees
Standard Deviation 8.150
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Lumbar cobb angle at baseline
|
-32.335 degrees
Standard Deviation 16.410
|
-33.101 degrees
Standard Deviation 15.179
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Local cobb angle of T5-L1 change at 1 month
|
1.126 degrees
Standard Deviation 5.639
|
1.608 degrees
Standard Deviation 5.631
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
Local cobb angle of L2-L4 change at 1 month
|
0.117 degrees
Standard Deviation 5.694
|
-1.149 degrees
Standard Deviation 5.576
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, post-operation, 1 month, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Kyphotic angle at baseline
|
9.523 degrees
Standard Deviation 8.751
|
10.806 degrees
Standard Deviation 8.962
|
11.005 degrees
Standard Deviation 8.798
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Kyphotic angle change at post-operation
|
1.312 degrees
Standard Deviation 4.909
|
NA degrees
Standard Deviation NA
Subjects did not have surgery.
|
1.438 degrees
Standard Deviation 4.191
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Kyphotic angle change at 12 month
|
0.954 degrees
Standard Deviation 5.626
|
-1.246 degrees
Standard Deviation 3.404
|
0.824 degrees
Standard Deviation 4.425
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Thoracic cobb angle at baseline
|
50.976 degrees
Standard Deviation 17.316
|
53.148 degrees
Standard Deviation 15.837
|
52.812 degrees
Standard Deviation 19.671
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Lumbar cobb angle change at 12 months
|
1.232 degrees
Standard Deviation 7.785
|
-1.412 degrees
Standard Deviation 3.634
|
2.057 degrees
Standard Deviation 13.535
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of T5-L1 at baseline
|
22.914 degrees
Standard Deviation 12.720
|
23.519 degrees
Standard Deviation 11.363
|
23.847 degrees
Standard Deviation 15.945
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of T5-L1 change at post-op
|
-0.506 degrees
Standard Deviation 4.231
|
NA degrees
Standard Deviation NA
Subjects did not have surgery.
|
-2.080 degrees
Standard Deviation 5.311
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of T5-L1 change at 1 month
|
1.126 degrees
Standard Deviation 5.639
|
0.357 degrees
Standard Deviation 7.731
|
-0.746 degrees
Standard Deviation 5.230
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of T5-L1 change at 12 months
|
1.550 degrees
Standard Deviation 5.525
|
1.638 degrees
Standard Deviation 1.998
|
-1.333 degrees
Standard Deviation 4.781
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of L2-L4 change at post-op
|
-1.834 degrees
Standard Deviation 7.886
|
NA degrees
Standard Deviation NA
Subjects did not have surgery.
|
-0.610 degrees
Standard Deviation 4.094
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of L2-L4 change at 1 month
|
0.117 degrees
Standard Deviation 5.694
|
-0.105 degrees
Standard Deviation 5.106
|
-0.770 degrees
Standard Deviation 3.376
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of L2-L4 change at 12 months
|
0.005 degrees
Standard Deviation 4.925
|
-0.346 degrees
Standard Deviation 3.197
|
-1.157 degrees
Standard Deviation 3.604
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Kyphotic angle change at 1 month
|
0.135 degrees
Standard Deviation 5.088
|
-0.130 degrees
Standard Deviation 4.203
|
0.637 degrees
Standard Deviation 4.545
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Thoracic cobb angle change at post-op
|
-1.804 degrees
Standard Deviation 9.701
|
NA degrees
Standard Deviation NA
Subjects did not have surgery.
|
-2.489 degrees
Standard Deviation 4.823
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Thoracic cobb angle change at 1 month
|
0.666 degrees
Standard Deviation 9.253
|
-1.633 degrees
Standard Deviation 8.212
|
-0.457 degrees
Standard Deviation 5.682
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Thoracic cobb angle change at 12 months
|
0.988 degrees
Standard Deviation 8.947
|
0.062 degrees
Standard Deviation 7.332
|
-1.372 degrees
Standard Deviation 6.187
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Lumbar cobb angle at baseline
|
-32.335 degrees
Standard Deviation 16.410
|
-31.218 degrees
Standard Deviation 12.656
|
-32.906 degrees
Standard Deviation 15.718
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Lumbar cobb angle change at post-op
|
-0.472 degrees
Standard Deviation 5.617
|
NA degrees
Standard Deviation NA
Subjects did not have surgery.
|
-1.396 degrees
Standard Deviation 4.575
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Lumbar cobb angle change at 1 month
|
0.626 degrees
Standard Deviation 7.075
|
5.661 degrees
Standard Deviation 10.117
|
0.839 degrees
Standard Deviation 5.336
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
Local cobb angle of L2-L4 at baseline
|
-7.715 degrees
Standard Deviation 15.470
|
-6.581 degrees
Standard Deviation 9.957
|
-6.945 degrees
Standard Deviation 14.496
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR at baseline
|
0.744 ratio
Standard Deviation 0.228
|
0.734 ratio
Standard Deviation 0.237
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR change at 1 month
|
0.016 ratio
Standard Deviation 0.123
|
-0.027 ratio
Standard Deviation 0.061
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior change at 1 month
|
0.007 ratio
Standard Deviation 0.081
|
-0.012 ratio
Standard Deviation 0.058
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR at baseline
|
0.782 ratio
Standard Deviation 0.193
|
0.776 ratio
Standard Deviation 0.190
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR change at 1 month
|
0.028 ratio
Standard Deviation 0.103
|
-0.017 ratio
Standard Deviation 0.068
|
—
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior VBHR at baseline
|
0.928 ratio
Standard Deviation 0.101
|
0.934 ratio
Standard Deviation 0.110
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, post-operation, 1 month, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR change at post-op
|
0.044 ratio
Standard Deviation 0.099
|
NA ratio
Standard Deviation NA
Subjects did not have surgery.
|
0.019 ratio
Standard Deviation 0.075
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR at baseline
|
0.744 ratio
Standard Deviation 0.228
|
0.767 ratio
Standard Deviation 0.254
|
0.741 ratio
Standard Deviation 0.224
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR change at post-op
|
0.060 ratio
Standard Deviation 0.117
|
NA ratio
Standard Deviation NA
Subjects did not have surgery.
|
0.024 ratio
Standard Deviation 0.084
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior VBHR change at 1 month
|
0.007 ratio
Standard Deviation 0.081
|
-0.022 ratio
Standard Deviation 0.045
|
0.016 ratio
Standard Deviation 0.069
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR change at 1 month
|
0.016 ratio
Standard Deviation 0.123
|
-0.036 ratio
Standard Deviation 0.054
|
0.006 ratio
Standard Deviation 0.065
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Anterior VBHR change at 12 months
|
0.022 ratio
Standard Deviation 0.129
|
-0.022 ratio
Standard Deviation 0.072
|
0.039 ratio
Standard Deviation 0.145
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR at baseline
|
0.782 ratio
Standard Deviation 0.193
|
0.741 ratio
Standard Deviation 0.239
|
0.800 ratio
Standard Deviation 0.176
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR change at 1 month
|
0.028 ratio
Standard Deviation 0.103
|
-0.031 ratio
Standard Deviation 0.074
|
0.012 ratio
Standard Deviation 0.071
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Medial VBHR change at 12 months
|
0.018 ratio
Standard Deviation 0.110
|
0.021 ratio
Standard Deviation 0.117
|
0.049 ratio
Standard Deviation 0.087
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior VBHR at baseline
|
0.928 ratio
Standard Deviation 0.101
|
0.899 ratio
Standard Deviation 0.166
|
0.951 ratio
Standard Deviation 0.110
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior VBHR change at post-op
|
0.007 ratio
Standard Deviation 0.064
|
NA ratio
Standard Deviation NA
Subjects did not have surgery.
|
-0.006 ratio
Standard Deviation 0.059
|
—
|
|
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
Posterior VBHR change at 12 months
|
-0.001 ratio
Standard Deviation 0.077
|
-0.026 ratio
Standard Deviation 0.049
|
0.006 ratio
Standard Deviation 0.053
|
—
|
SECONDARY outcome
Timeframe: Baseline, 7 days, and 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Back Pain Analgesics Used
Back pain analgesic use at 1 month
|
60 percentage of participants
|
72 percentage of participants
|
—
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at baseline
|
96 percentage of participants
|
84 percentage of participants
|
—
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 7 days
|
82 percentage of participants
|
80 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Back Pain Analgesics Used
Back pain analgesic use at baseline
|
96 percentage of participants
|
78 percentage of participants
|
87 percentage of participants
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 7 days
|
82 percentage of participants
|
61 percentage of participants
|
68 percentage of participants
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 1 month
|
60 percentage of participants
|
39 percentage of participants
|
66 percentage of participants
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 3 months
|
43 percentage of participants
|
30 percentage of participants
|
58 percentage of participants
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 6 months
|
40 percentage of participants
|
22 percentage of participants
|
39 percentage of participants
|
—
|
|
Back Pain Analgesics Used
Back pain analgesic use at 12 months
|
19 percentage of participants
|
13 percentage of participants
|
26 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurology Status From Baseline (Motor Strength)
Improved at 1 month
|
8.8 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)
Worsened at 1 month
|
1.5 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)
Unchanged at 1 month
|
84 percentage of participants
|
74 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Unchanged at 1 month
|
84 percentage of participants
|
39 percentage of participants
|
92 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Improved at 3 months
|
7.4 percentage of participants
|
4.3 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Unchanged at 3 months
|
68 percentage of participants
|
35 percentage of participants
|
84 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Worsened at 3 months
|
2.9 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Worsened at 6 months
|
4.4 percentage of participants
|
0.0 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Worsened at 12 months
|
2.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Improved at 1 month
|
8.8 percentage of participants
|
8.7 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Worsened at in month
|
1.5 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Improved at 6 months
|
5.9 percentage of participants
|
4.3 percentage of participants
|
11 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Unchanged at 6 months
|
62 percentage of participants
|
30 percentage of participants
|
68 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Improved at 12 months
|
2.9 percentage of participants
|
4.3 percentage of participants
|
5.3 percentage of participants
|
—
|
|
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
Unchanged at 12 months
|
53 percentage of participants
|
22 percentage of participants
|
66 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Sensory Examination)
Improved
|
2.9 percentage of participants
|
1.6 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Unchanged
|
91 percentage of participants
|
79 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Worsened
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 months, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Sensory Examination)
Improved at 3 months
|
1.5 percentage of participants
|
0.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Improved at 6 months
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Unchanged at 6 months
|
71 percentage of participants
|
35 percentage of participants
|
84 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Worsened at 6 months
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Improved at 12 months
|
1.5 percentage of participants
|
4.3 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Unchanged at 12 months
|
57 percentage of participants
|
22 percentage of participants
|
66 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Worsened at 12 months
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.3 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Improved at 1 month
|
2.9 percentage of participants
|
0.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Unchanged at 1 month
|
91 percentage of participants
|
52 percentage of participants
|
95 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Worsened at 1 month
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Unchanged at 3 months
|
78 percentage of participants
|
43 percentage of participants
|
92 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Sensory Examination)
Worsened at 3 months
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Reflex Strength)
Worsened
|
1.5 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Improved
|
7.4 percentage of participants
|
8.2 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Unchanged
|
85 percentage of participants
|
69 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 months, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Reflex Strength)
Improved at 1 month
|
7.4 percentage of participants
|
4.3 percentage of participants
|
5.3 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Unchanged at 1 month
|
85 percentage of participants
|
43 percentage of participants
|
82 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Worsened at 1 month
|
1.5 percentage of participants
|
4.3 percentage of participants
|
11.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Improved at 3 months
|
2.9 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Worsened at 6 months
|
1.5 percentage of participants
|
0.0 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Improved at 12 months
|
2.9 percentage of participants
|
0.0 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Worsened at 12 months
|
2.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Unchanged at 3 months
|
74 percentage of participants
|
39 percentage of participants
|
82 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Worsened at 3 months
|
2.9 percentage of participants
|
0.0 percentage of participants
|
11.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Improved at 6 months
|
5.9 percentage of participants
|
0.0 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Unchanged at 6 months
|
65 percentage of participants
|
35 percentage of participants
|
71 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Reflex Strength)
Unchanged at 12 months
|
53 percentage of participants
|
26 percentage of participants
|
63 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=61 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Limb Strength)
Improved
|
12 percentage of participants
|
4.9 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Unchanged
|
81 percentage of participants
|
67 percentage of participants
|
—
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Worsened
|
1.5 percentage of participants
|
8.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 months, 3 months, 6 months, and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Change in Neurological Status From Baseline (Limb Strength)
Improved at 1 month
|
12 percentage of participants
|
0.0 percentage of participants
|
16 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Unchanged at 3 months
|
71 percentage of participants
|
39 percentage of participants
|
79 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Worsened at 3 months
|
4.4 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Improved at 6 months
|
7.4 percentage of participants
|
0.0 percentage of participants
|
13 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Unchanged at 6 months
|
63 percentage of participants
|
30 percentage of participants
|
71 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Worsened at 6 months
|
1.5 percentage of participants
|
4.3 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Improved at 12 months
|
4.4 percentage of participants
|
4.3 percentage of participants
|
11 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Unchanged at 12 months
|
51 percentage of participants
|
22 percentage of participants
|
58 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Unchanged at 1 month
|
81 percentage of participants
|
48 percentage of participants
|
82 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Worsened at 1 month
|
1.5 percentage of participants
|
4.3 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Improved at 3 months
|
4.4 percentage of participants
|
0.0 percentage of participants
|
13 percentage of participants
|
—
|
|
Change in Neurological Status From Baseline (Limb Strength)
Worsened at 12 months
|
2.9 percentage of participants
|
0.0 percentage of participants
|
2.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All of the randomized subjects were included in safety population analysis.
The study treatment-related AEs were defined as follows: 1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. 2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. 3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. 4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=70 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=64 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
Unrelated
|
33 percentage of participants
|
30 percentage of participants
|
—
|
—
|
|
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
Possibly related
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
Related
|
4.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
Unknown
|
2.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All of randomized subjects were included in safety population analysis.
The study treatment-related AEs were defined as follows: 1. Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. 2. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. 3. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. 4. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=70 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=26 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Rate of Study Treatment-related Adverse Events Till Study Completion
Unknown
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.9 percentage of participants
|
|
Rate of Study Treatment-related Adverse Events Till Study Completion
Unrelated
|
77 percentage of participants
|
50 percentage of participants
|
37 percentage of participants
|
79 percentage of participants
|
|
Rate of Study Treatment-related Adverse Events Till Study Completion
Possibly related
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
|
Rate of Study Treatment-related Adverse Events Till Study Completion
Related
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=62 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=47 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Rate of Subsequent Vertebral Body Fractures
|
19.6 percentage of participants
|
17.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month and 12 monthsPopulation: The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
Based on patients with at least 7 analyzable vertebrae.
Outcome measures
| Measure |
Balloon Kyphoplasty
n=68 Participants
The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=23 Participants
The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
Crossover
n=38 Participants
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
Crossover-(AEs Collected After BKP)
Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
|
|---|---|---|---|---|
|
Rate of Subsequent Vertebral Body Fractures
1 month
|
19.4 percentage of participants
|
23.1 percentage of participants
|
11.8 percentage of participants
|
—
|
|
Rate of Subsequent Vertebral Body Fractures
12 months
|
13.2 percentage of participants
|
0.0 percentage of participants
|
7.4 percentage of participants
|
—
|
Adverse Events
Balloon Kyphoplasty
Serious events: 15 serious events
Other events: 16 other events
Deaths: 0 deaths
Non Surgical Management
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balloon Kyphoplasty
n=70 participants at risk
The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=64 participants at risk
The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
2.9%
2/70 • Number of events 2 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Gastric hypomotility
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
General disorders
Asthenia
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
General disorders
General Physical Health Deterioration
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
General disorders
Malaise
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
General disorders
Pyrexia
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Staphylococcal Infection
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Injury, poisoning and procedural complications
Post Procedural Myocardial Infarction
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
6.2%
4/64 • Number of events 4 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Vertebral Fracture
|
2.9%
2/70 • Number of events 4 • Adverse Events within 30 Days of treatment
|
4.7%
3/64 • Number of events 4 • Adverse Events within 30 Days of treatment
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Nervous system disorders
Paresis
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
Other adverse events
| Measure |
Balloon Kyphoplasty
n=70 participants at risk
The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.
|
Non Surgical Management
n=64 participants at risk
The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Eye disorders
Diplopia
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Diarrhoea Haemorrhagic
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
General disorders
Implant Site Extravasation
|
2.9%
2/70 • Number of events 2 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Laryngitis
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Urinary Tract Infection
|
2.9%
2/70 • Number of events 2 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Infections and infestations
Wound Infection
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Injury, poisoning and procedural complications
Device Breakage
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Investigations
Haemoglobin Decreased
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.3%
3/70 • Number of events 3 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Musculoskeletal and connective tissue disorders
Vertebral Fracture
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Number of events 1 • Adverse Events within 30 Days of treatment
|
0.00%
0/64 • Adverse Events within 30 Days of treatment
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/70 • Adverse Events within 30 Days of treatment
|
1.6%
1/64 • Number of events 1 • Adverse Events within 30 Days of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60