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Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs (EVOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01871519
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Compression Fracture of Vertebral Body
Osteoporosis
Cancer
Intervention Device: Balloon kyphoplasty
Enrollment 354
Recruitment Details A total of 354 subjects were enrolled in this study. Among them, 350 subjects had BKP surgery and 4 subjects were not treated with BKP. Two of the non-treated subjects voluntarily withdrew from the study and 2 subjects were lost-to-follow-up before surgery.
Pre-assignment Details  
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Period Title: Overall Study
Started 350
Completed 260
Not Completed 90
Reason Not Completed
Death             26
Lost to Follow-up             15
Withdrawal by Subject             49
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Baseline Participants 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 350 participants
78.9  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 350 participants
Female
272
  77.7%
Male
78
  22.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 350 participants
Hispanic or Latino
6
   1.7%
Not Hispanic or Latino
344
  98.3%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 350 participants
1
   0.3%
Asian Number Analyzed 350 participants
12
   3.4%
Black or African American Number Analyzed 350 participants
4
   1.1%
Native Hawaiian or other pacific islander Number Analyzed 350 participants
0
   0.0%
White Number Analyzed 350 participants
330
  94.3%
Other Number Analyzed 350 participants
3
   0.9%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 350 participants
64.3  (3.9)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 350 participants
153.9  (36.9)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 350 participants
26.1  (5.5)
Estimated pre-fracture vertebral body height   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Anterior Number Analyzed 344 participants
24.940  (4.811)
Middle Number Analyzed 344 participants
24.207  (4.264)
Posterior Number Analyzed 344 participants
26.502  (4.397)
[1]
Measure Analysis Population Description: A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.
1.Primary Outcome
Title Back Pain Change From Baseline at 3 Months
Hide Description Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame Baseline, 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: units on a scale
Back pain at baseline Number Analyzed 350 participants
8.7  (1.2)
Back pain at 3 Months Number Analyzed 293 participants
2.7  (2.7)
Back pain change Number Analyzed 293 participants
-6.0  (3.0)
2.Primary Outcome
Title Back Function Change From Baseline by Oswestry Disability Index at 3 Months
Hide Description ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame Baseline, 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: units on a scale
ODI score at baseline Number Analyzed 350 participants
63.4  (14.9)
ODI score at 3 months Number Analyzed 283 participants
27.1  (18.8)
ODI change Number Analyzed 283 participants
-35.3  (20.5)
3.Primary Outcome
Title SF-36v2 Physical Component Summary Change From Baseline at 3 Months
Hide Description Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Time Frame Baseline, 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 346
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 PCS at baseline Number Analyzed 346 participants
24.2  (7.0)
SF-36 PCS at 3 months Number Analyzed 279 participants
36.6  (11.2)
SF-36 PCS change Number Analyzed 276 participants
12.4  (11.4)
4.Primary Outcome
Title Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months
Hide Description EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Time Frame Baseline, 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 348
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D index at baseline Number Analyzed 348 participants
0.383  (0.212)
EQ-5D index at 3 months Number Analyzed 281 participants
0.746  (0.194)
EQ-5D index score change Number Analyzed 279 participants
0.351  (0.267)
5.Secondary Outcome
Title Back Pain
Hide Description Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: units on a scale
Back pain at baseline Number Analyzed 350 participants
8.7  (1.2)
Back pain at 7 days Number Analyzed 340 participants
3.4  (2.3)
Back pain at 30 days Number Analyzed 315 participants
3.2  (2.7)
Back pain at 6 months Number Analyzed 265 participants
2.5  (2.7)
Back pain at 9 months Number Analyzed 277 participants
2.3  (2.6)
Back pain at 12 months Number Analyzed 257 participants
2.4  (2.8)
6.Secondary Outcome
Title Back Function (ODI)
Hide Description ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame Baseline, 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: units on a scale
ODI score at baseline Number Analyzed 350 participants
63.4  (14.9)
ODI score at 30 days Number Analyzed 304 participants
32.5  (19.5)
ODI score at 6 months Number Analyzed 255 participants
25.7  (19.0)
ODI score at 12 months Number Analyzed 247 participants
25.8  (19.0)
7.Secondary Outcome
Title Quality of Life by SF-36v2 PCS
Hide Description Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Time Frame Baseline, 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 346
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 PCS at baseline Number Analyzed 346 participants
24.2  (7.0)
SF-36 PCS at 30 days Number Analyzed 301 participants
34.9  (9.8)
SF-36 PCS at 6 months Number Analyzed 253 participants
37.6  (11.5)
SF-36 PCS at 12 months Number Analyzed 247 participants
38.2  (12.1)
8.Secondary Outcome
Title Quality of Life by EQ-5D Index Score
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 348
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D index at baseline Number Analyzed 348 participants
0.383  (0.212)
EQ-5D index at 30 days Number Analyzed 302 participants
0.710  (0.196)
EQ-5D index at 6 months Number Analyzed 254 participants
0.756  (0.193)
EQ-5D index at 12 months Number Analyzed 245 participants
0.758  (0.193)
9.Secondary Outcome
Title Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 3 months, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 350 participants
96.3
30 days Number Analyzed 304 participants
53.3
3 months Number Analyzed 283 participants
31.8
6 months Number Analyzed 255 participants
31.0
12 months Number Analyzed 246 participants
28.9
10.Secondary Outcome
Title The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 3 months, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Mean (Standard Deviation)
Unit of Measure: days
days of limited activities at baseline Number Analyzed 349 participants
11.0  (4.6)
days of bed rest at baseline Number Analyzed 348 participants
6.0  (5.9)
days of limited activities at 30 days Number Analyzed 303 participants
4.7  (5.7)
days of bed rest at 30 days Number Analyzed 304 participants
1.5  (3.5)
days of limited activities at 3 months Number Analyzed 278 participants
2.6  (4.6)
days of bed rest at 3 months Number Analyzed 280 participants
0.7  (2.3)
days of limited activities at 6 months Number Analyzed 252 participants
2.6  (4.8)
days of bed rest at 6 months Number Analyzed 253 participants
0.7  (2.5)
days of limited activities at 12 months Number Analyzed 244 participants
2.2  (4.5)
days of bed rest at 12 months Number Analyzed 245 participants
0.7  (2.4)
11.Secondary Outcome
Title Ambulatory Status
Hide Description [Not Specified]
Time Frame Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices

Overall Number of Participants Analyzed 350
Measure Type: Number
Unit of Measure: percentage of participants
Able to walk at baseline Number Analyzed 350 participants
42.3
Walk with aid at baseline Number Analyzed 350 participants
50.3
Unable to walk at baseline Number Analyzed 350 participants
7.4
Able to walk at 7 days Number Analyzed 339 participants
59.9
Walk with aid at 7 days Number Analyzed 339 participants
38.3
Unable to walk at 7 days Number Analyzed 339 participants
1.8
Able to walk at 30 days Number Analyzed 315 participants
62.5
Walk with aid at 30 days Number Analyzed 315 participants
36.2
Unable to walk at 30 days Number Analyzed 315 participants
1.3
Able to walk at 3 months Number Analyzed 293 participants
64.5
Walk with aid at 3 months Number Analyzed 293 participants
34.1
Unable to walk at 3 months Number Analyzed 293 participants
1.4
Able to walk at 6 months Number Analyzed 266 participants
62.4
Walk with aid at 6 months Number Analyzed 266 participants
36.1
Unable to walk at 6 months Number Analyzed 266 participants
1.5
Able to walk at 9 months Number Analyzed 278 participants
68.7
Walk with aid at 9 months Number Analyzed 278 participants
30.9
Unable to walk at 9 months Number Analyzed 278 participants
0.4
Able to walk at 12 months Number Analyzed 258 participants
63.2
Walk with aid at 12months Number Analyzed 258 participants
35.7
Unable to walk at 12 months Number Analyzed 258 participants
1.2
12.Secondary Outcome
Title Barthel Index (Only for Subjects With Osteoporosis)
Hide Description For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).
Time Frame Baseline, 30 days, 3 months 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 343
Mean (Standard Deviation)
Unit of Measure: units on a scale
Barthel index score at baseline Number Analyzed 343 participants
16.2  (4.0)
Barthel index score at 30 days Number Analyzed 299 participants
18.8  (2.1)
Barthel index score at 3 months Number Analyzed 280 participants
19.1  (2.0)
Barthel index score at 6 months Number Analyzed 253 participants
19.1  (1.8)
Barthel index score at 12 months Number Analyzed 244 participants
19.1  (1.8)
13.Secondary Outcome
Title Karnofsky Performance Scale
Hide Description For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.
Time Frame Baseline, 30 days, 3 months 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Karnofsky performance scale at baseline Number Analyzed 7 participants
75.7  (21.5)
Karnofsky performance scale at 30 days Number Analyzed 5 participants
88.0  (11.0)
Karnofsky performance scale at 3 months Number Analyzed 4 participants
90.0  (14.1)
Karnofsky performance scale at 6 months Number Analyzed 4 participants
85.0  (30.0)
Karnofsky performance scale at 12 months Number Analyzed 3 participants
96.7  (5.8)
14.Secondary Outcome
Title Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)
Hide Description AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.
Time Frame Baseline, pre-discharge, 3 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 344
Overall Number of Units Analyzed
Type of Units Analyzed: Treated levels
490
Mean (Standard Deviation)
Unit of Measure: percentage of pre-fracture height
Anterior height Loss from EP at baseline Number Analyzed 435 Treated levels [1] 
-26.438  (22.008)
Middle height loss from EP at baseline Number Analyzed 435 Treated levels [1] 
-27.719  (20.861)
Posterior height loss from EP at baseline Number Analyzed 435 Treated levels [1] 
-8.228  (10.966)
Anterior AHRP at pre-discharge Number Analyzed 407 Treated levels [2] 
3.897  (9.822)
Middle AHRP at pre-discharge Number Analyzed 407 Treated levels [2] 
4.205  (9.783)
Posterior AHRP at pre-discharge Number Analyzed 407 Treated levels [2] 
1.280  (7.280)
Anterior AHRP at 3 months Number Analyzed 340 Treated levels [3] 
1.511  (10.426)
Middle AHRP at 3 months Number Analyzed 340 Treated levels [3] 
2.223  (10.076)
Posterior AHRP at 3 months Number Analyzed 340 Treated levels [3] 
0.101  (7.474)
Anterior AHRP at 12 months Number Analyzed 273 Treated levels [4] 
1.308  (10.765)
Middle AHRP at 12 months Number Analyzed 273 Treated levels [4] 
1.567  (10.453)
Posterior AHRP at 12 months Number Analyzed 273 Treated levels [4] 
-0.028  (8.284)
[1]
312 participants
[2]
291 participants
[3]
249 participants
[4]
203 participants
15.Secondary Outcome
Title Vertebral Body Angle
Hide Description The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.
Time Frame Baseline, pre-discharge, 3 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 344
Overall Number of Units Analyzed
Type of Units Analyzed: Treated levels
490
Mean (Standard Deviation)
Unit of Measure: degrees
vertebral body angle at baseline Number Analyzed 440 Treated levels [1] 
-10.474  (8.152)
Vertebral body angle at pre-discharge Number Analyzed 449 Treated levels [2] 
-9.522  (6.867)
Angle change from baseline at pre-discharge Number Analyzed 408 Treated levels [3] 
1.117  (4.137)
Vertebral body angle at 3 months Number Analyzed 372 Treated levels [4] 
-10.119  (6.781)
Angle change from baseline at 3 months Number Analyzed 341 Treated levels [5] 
0.633  (4.282)
Vertebral body angle at 12 months Number Analyzed 311 Treated levels [6] 
-9.876  (6.714)
Angle change from baseline at 12 months Number Analyzed 277 Treated levels [7] 
0.748  (4.315)
[1]
313 participants
[2]
317 participants
[3]
291 participants
[4]
269 participants
[5]
249 participants
[6]
227 participants
[7]
204 participants
16.Secondary Outcome
Title Local Cobb Angle
Hide Description The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.
Time Frame Baseline, pre-discharge, 3 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 344
Overall Number of Units Analyzed
Type of Units Analyzed: Treated levels
490
Mean (Standard Deviation)
Unit of Measure: degrees
Local Cobb angle at baseline Number Analyzed 417 Treated levels [1] 
-12.919  (18.302)
Local Cobb angle at pre-discharge Number Analyzed 429 Treated levels [2] 
-11.190  (17.244)
Angle change from baseline at pre-discharge Number Analyzed 382 Treated levels [3] 
2.707  (5.102)
Local Cobb angle at 3 months Number Analyzed 359 Treated levels [4] 
-13.439  (17.843)
Angle change from baseline at 3 months Number Analyzed 322 Treated levels [5] 
0.253  (5.979)
Local Cobb angle at 12 months Number Analyzed 299 Treated levels [6] 
-12.819  (18.643)
Angle change from baseline at 12 months Number Analyzed 264 Treated levels [7] 
-0.197  (6.106)
[1]
306 participants
[2]
311 participants
[3]
283 participants
[4]
264 participants
[5]
243 participants
[6]
222 participants
[7]
201 participants
17.Secondary Outcome
Title Subsequent Radiographic Fractures
Hide Description A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.
Time Frame 3 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: percentage of participants
Subsequent fractures at 3 months Number Analyzed 267 participants
36.7
Subsequent fractures at 12 months Number Analyzed 246 participants
47.6
18.Secondary Outcome
Title Neurological Success Rate
Hide Description Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.
Time Frame Pre-discharge, 30 days, 3 months, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description:

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Overall Number of Participants Analyzed 350
Measure Type: Number
Unit of Measure: percentage of participants
Neurological success at predischarge Number Analyzed 337 participants
79.2
Neurological success at 30 days Number Analyzed 313 participants
76.7
Neurological success at 3 months Number Analyzed 292 participants
76.4
Neurological success at 6 months Number Analyzed 265 participants
74.3
Neurological success at 12 months Number Analyzed 257 participants
76.7
Time Frame Overall study about 12-month follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Balloon Kyphoplasty
Hide Arm/Group Description

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

All-Cause Mortality
Balloon Kyphoplasty
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Balloon Kyphoplasty
Affected / at Risk (%) # Events
Total   79/350 (22.57%)    
Cardiac disorders   
Atrial fibrillation  1/350 (0.29%)  1
Cardiac arrest  2/350 (0.57%)  2
Cardiac failure congestive  1/350 (0.29%)  1
Cardio-respiratory arrest  1/350 (0.29%)  1
Coronary artery disease  1/350 (0.29%)  1
Myocardial infarction  1/350 (0.29%)  1
Tachycardia  1/350 (0.29%)  1
Eye disorders   
Cataract  1/350 (0.29%)  1
Gastrointestinal disorders   
Abdominal pain  1/350 (0.29%)  1
Colitis ulcerative  1/350 (0.29%)  1
Diverticulitis intestinal haemorrhagic  1/350 (0.29%)  1
Femoral hernia, obstructive  1/350 (0.29%)  1
Gastrointestinal haemorrhage  1/350 (0.29%)  1
Lower gastrointestinal haemorrhage  1/350 (0.29%)  1
Pancreatitis  1/350 (0.29%)  1
General disorders   
General physical health deterioration  1/350 (0.29%)  1
Hepatobiliary disorders   
Cholelithiasis  2/350 (0.57%)  2
Chronic hepatic failure  1/350 (0.29%)  1
Lupus hepatitis  1/350 (0.29%)  1
Infections and infestations   
Cellulitis  1/350 (0.29%)  1
Pneumonia  3/350 (0.86%)  3
Urinary tract infection  1/350 (0.29%)  1
Injury, poisoning and procedural complications   
Fall  3/350 (0.86%)  3
Femoral neck fracture  1/350 (0.29%)  1
Femur fracture  1/350 (0.29%)  1
Hip fracture  2/350 (0.57%)  2
Lower limb fracture  1/350 (0.29%)  1
Lumbar vertebral fracture  2/350 (0.57%)  3
Pelvic fracture  1/350 (0.29%)  1
Spinal compression fracture  11/350 (3.14%)  14
Spinal fracture  2/350 (0.57%)  2
Thoracic vertebral fracture  2/350 (0.57%)  2
Metabolism and nutrition disorders   
Dehydration  1/350 (0.29%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  2/350 (0.57%)  2
Back pain  17/350 (4.86%)  26
Intervertebral disc degeneration  1/350 (0.29%)  1
Intervertebral disc protrusion  1/350 (0.29%)  1
Metatarsalgia  1/350 (0.29%)  1
Spinal pain  2/350 (0.57%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1/350 (0.29%)  1
Bladder cancer  1/350 (0.29%)  1
Malignant neoplasm progression  1/350 (0.29%)  1
Mesothelioma malignant  1/350 (0.29%)  1
Plasma cell myeloma  2/350 (0.57%)  2
Nervous system disorders   
Cerebrovascular accident  1/350 (0.29%)  1
Hydrocephalus  1/350 (0.29%)  1
Sciatica  1/350 (0.29%)  1
Transient ischaemic attack  2/350 (0.57%)  2
Renal and urinary disorders   
Haematuria  1/350 (0.29%)  1
Renal failure  1/350 (0.29%)  1
Renal failure chronic  1/350 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1/350 (0.29%)  1
Aspiration  1/350 (0.29%)  1
Asthma  1/350 (0.29%)  1
Chronic obstructive pulmonary disease  5/350 (1.43%)  7
Pneumonia aspiration  1/350 (0.29%)  1
Pneumothorax  1/350 (0.29%)  1
Respiratory arrest  1/350 (0.29%)  1
Respiratory failure  4/350 (1.14%)  4
Vascular disorders   
Vascular stenosis  1/350 (0.29%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Balloon Kyphoplasty
Affected / at Risk (%) # Events
Total   128/350 (36.57%)    
Blood and lymphatic system disorders   
Iron deficiency anaemia  1/350 (0.29%)  1
Cardiac disorders   
Atrial fibrillation  2/350 (0.57%)  2
Atrioventricular block  1/350 (0.29%)  1
Cardiac failure congestive  1/350 (0.29%)  1
Supraventricular tachycardia  1/350 (0.29%)  1
Tachyarrhythmia  1/350 (0.29%)  1
Ear and labyrinth disorders   
Vertigo  2/350 (0.57%)  2
Gastrointestinal disorders   
Abdominal hernia  1/350 (0.29%)  1
Abdominal pain lower  1/350 (0.29%)  1
Abdominal pain upper  2/350 (0.57%)  2
Coeliac disease  1/350 (0.29%)  1
Constipation  1/350 (0.29%)  1
Diarrhoea  1/350 (0.29%)  1
Faecal incontinence  1/350 (0.29%)  1
Inguinal hernia  1/350 (0.29%)  1
General disorders   
Death  1/350 (0.29%)  1
Device breakage  1/350 (0.29%)  1
Device malfunction  1/350 (0.29%)  1
Implant site extravasation  1/350 (0.29%)  1
Oedema peripheral  1/350 (0.29%)  1
Pain  1/350 (0.29%)  1
Hepatobiliary disorders   
Cholelithiasis  1/350 (0.29%)  1
Infections and infestations   
Bronchitis  2/350 (0.57%)  2
Cystitis  1/350 (0.29%)  1
Herpes zoster  2/350 (0.57%)  2
Kidney infection  1/350 (0.29%)  1
Pneumonia  2/350 (0.57%)  2
Upper respiratory tract infection  1/350 (0.29%)  1
Urinary tract infection  1/350 (0.29%)  1
Injury, poisoning and procedural complications   
Compression fracture  1/350 (0.29%)  1
Contusion  2/350 (0.57%)  2
Fall  9/350 (2.57%)  9
Hip fracture  1/350 (0.29%)  1
Humerus fracture  1/350 (0.29%)  1
Incision site haemorrhage  1/350 (0.29%)  1
Laceration  2/350 (0.57%)  2
Ligament sprain  1/350 (0.29%)  1
Lumbar vertebral fracture  2/350 (0.57%)  2
Muscle strain  2/350 (0.57%)  2
Radius fracture  1/350 (0.29%)  1
Rib fracture  4/350 (1.14%)  4
Road traffic accident  1/350 (0.29%)  1
Spinal compression fracture  18/350 (5.14%)  18
Spinal fracture  1/350 (0.29%)  1
Thoracic vertebral fracture  4/350 (1.14%)  4
Upper limb fracture  1/350 (0.29%)  1
Wound dehiscence  1/350 (0.29%)  1
Metabolism and nutrition disorders   
Dehydration  1/350 (0.29%)  1
Hyponatraemia  1/350 (0.29%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  8/350 (2.29%)  8
Arthritis  11/350 (3.14%)  11
Back pain  27/350 (7.71%)  30
Bone pain  1/350 (0.29%)  1
Bursitis  4/350 (1.14%)  5
Cervical spinal stenosis  1/350 (0.29%)  1
Costochondritis  1/350 (0.29%)  1
Facet joint syndrome  2/350 (0.57%)  2
Fracture nonunion  1/350 (0.29%)  1
Intervertebral disc disorder  1/350 (0.29%)  1
Kyphosis  10/350 (2.86%)  10
Lumbar spinal stenosis  1/350 (0.29%)  1
Musculoskeletal chest pain  3/350 (0.86%)  3
Musculoskeletal discomfort  1/350 (0.29%)  1
Musculoskeletal pain  3/350 (0.86%)  3
Myofascial pain syndrome  1/350 (0.29%)  1
Neck pain  3/350 (0.86%)  3
Osteoarthritis  1/350 (0.29%)  1
Osteoporosis  1/350 (0.29%)  1
Pain in extremity  3/350 (0.86%)  3
Pathological fracture  1/350 (0.29%)  1
Sacroiliitis  6/350 (1.71%)  6
Scoliosis  4/350 (1.14%)  4
Spinal column stenosis  1/350 (0.29%)  1
Spinal deformity  1/350 (0.29%)  1
Spinal osteoarthritis  2/350 (0.57%)  2
Spinal pain  2/350 (0.57%)  2
Spondylolisthesis  4/350 (1.14%)  4
Tendonitis  1/350 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant  1/350 (0.29%)  1
Metastatic pain  1/350 (0.29%)  1
Nervous system disorders   
Balance disorder  2/350 (0.57%)  2
Carpal tunnel syndrome  1/350 (0.29%)  1
Cerebrovascular accident  1/350 (0.29%)  1
Convulsion  1/350 (0.29%)  1
Dizziness  3/350 (0.86%)  3
Haemorrhage intracranial  1/350 (0.29%)  1
Headache  2/350 (0.57%)  2
Hypoaesthesia  1/350 (0.29%)  1
Neuropathy peripheral  1/350 (0.29%)  1
Radiculitis  1/350 (0.29%)  1
Radiculopathy  2/350 (0.57%)  2
Spinal cord compression  1/350 (0.29%)  1
Syncope  1/350 (0.29%)  1
Transient ischaemic attack  1/350 (0.29%)  1
Unresponsive to stimuli  1/350 (0.29%)  1
Psychiatric disorders   
Insomnia  1/350 (0.29%)  1
Mental status changes  1/350 (0.29%)  1
Renal and urinary disorders   
Renal failure  1/350 (0.29%)  1
Urinary incontinence  1/350 (0.29%)  1
Reproductive system and breast disorders   
Pelvic pain  1/350 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchiectasis  1/350 (0.29%)  1
Chronic obstructive pulmonary disease  1/350 (0.29%)  1
Epistaxis  1/350 (0.29%)  1
Pulmonary fibrosis  1/350 (0.29%)  1
Skin and subcutaneous tissue disorders   
Skin irritation  1/350 (0.29%)  1
Skin lesion  1/350 (0.29%)  1
Skin ulcer  1/350 (0.29%)  1
Vascular disorders   
Deep vein thrombosis  1/350 (0.29%)  1
Haematoma  1/350 (0.29%)  1
Hypertensive crisis  1/350 (0.29%)  1
Labile hypertension  1/350 (0.29%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Department
Organization: Medtronic Spinal
Phone: 1800-876-3133 ext 6068
EMail: msbkclinicalresearch@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01871519    
Other Study ID Numbers: P12-03
First Submitted: June 4, 2013
First Posted: June 6, 2013
Results First Submitted: December 14, 2016
Results First Posted: February 7, 2017
Last Update Posted: March 29, 2017