Trial Outcomes & Findings for Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty (NCT NCT00810043)
NCT ID: NCT00810043
Last Updated: 2017-12-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Baseline and 48-hr post-procedure
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
Curette-First
Use of the curette prior to use of the inflatable bone tamps
|
IBT-First
Use of the inflatable bone tamps prior to using the curette
|
Non-treated Patients
Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
8
|
|
Overall Study
COMPLETED
|
53
|
54
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
8
|
Reasons for withdrawal
| Measure |
Curette-First
Use of the curette prior to use of the inflatable bone tamps
|
IBT-First
Use of the inflatable bone tamps prior to using the curette
|
Non-treated Patients
Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Unrelated medical problem
|
0
|
1
|
0
|
|
Overall Study
Non-medical problem
|
0
|
0
|
1
|
|
Overall Study
No longer met enrollment criteria
|
0
|
0
|
3
|
Baseline Characteristics
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Baseline characteristics by cohort
| Measure |
Curette-First
n=57 Participants
Use of the curette prior to use of the inflatable bone tamps
|
IBT-First
n=55 Participants
Use of the inflatable bone tamps prior to using the curette
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
76.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
74.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Smoking history
Never Smoked
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Smoking history
Current Smoker
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Smoking history
Former Smoker
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 48-hr post-procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Anterior vertebral measurement (n=52, 50)
|
9.72 percent change
Standard Deviation 12.85 • Interval 6.1 to 13.3
|
11.77 percent change
Standard Deviation 13.23 • Interval 8.0 to 15.5
|
|
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Mid-vertebral measurement (n=52, 50)
|
8.14 percent change
Standard Deviation 9.96 • Interval 5.4 to 10.9
|
9.07 percent change
Standard Deviation 10.31 • Interval 6.1 to 12.0
|
|
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Posterior vertebral measurement (n=52, 50)
|
2.59 percent change
Standard Deviation 5.15 • Interval 1.2 to 4.0
|
4.21 percent change
Standard Deviation 6.49 • Interval 2.4 to 6.1
|
SECONDARY outcome
Timeframe: Baseline and 48 hours after procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Index Vertebral Body Height Restored in Millimeters.
Midpoint VBH at baseline (n=54, 53)
|
13.98 mm
Standard Deviation 4.12
|
14.21 mm
Standard Deviation 4.07
|
|
Index Vertebral Body Height Restored in Millimeters.
Anterior VBH at baseline (n=54, 53)
|
14.15 mm
Standard Deviation 5.25
|
14.27 mm
Standard Deviation 5.02
|
|
Index Vertebral Body Height Restored in Millimeters.
Anterior VBH at 48 hr post-procedure (n=56, 51)
|
16.65 mm
Standard Deviation 4.75
|
17.32 mm
Standard Deviation 4.33
|
|
Index Vertebral Body Height Restored in Millimeters.
Anterior change in VBH (n=53, 50)
|
2.28 mm
Standard Deviation 2.89
|
2.78 mm
Standard Deviation 3.11
|
|
Index Vertebral Body Height Restored in Millimeters.
Midpoint VBH at 48 hr post-procedure (n=56, 51)
|
16.22 mm
Standard Deviation 4.01
|
16.62 mm
Standard Deviation 3.39
|
|
Index Vertebral Body Height Restored in Millimeters.
Midpoint change in VBH (n=53, 50)
|
1.98 mm
Standard Deviation 2.38
|
2.25 mm
Standard Deviation 2.58
|
|
Index Vertebral Body Height Restored in Millimeters.
Posterior VBH at baseline (n=54, 53)
|
22.79 mm
Standard Deviation 3.61
|
22.94 mm
Standard Deviation 4.32
|
|
Index Vertebral Body Height Restored in Millimeters.
Posterior VBH at 48 hr post-procedure (n=56, 51)
|
23.57 mm
Standard Deviation 3.99
|
24.02 mm
Standard Deviation 3.59
|
|
Index Vertebral Body Height Restored in Millimeters.
Posterior change in VBH (n=53, 50)
|
0.65 mm
Standard Deviation 1.29
|
1.05 mm
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.
Outcome measures
| Measure |
Curette-First
n=55 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Anterior VBH at intra-op with Bolster (n=47)
|
17.03 mm
Standard Deviation 4.72
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Anterior VBH at Intra-op 1st IBT (n=49)
|
18.40 mm
Standard Deviation 4.67
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Anterior VBH change (n=47)
|
1.25 mm
Standard Deviation 1.94
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Middle VBH at intra-op with Bolster (n=47)
|
15.99 mm
Standard Deviation 3.60
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Middle VBH at Intra-op 1st IBT (n=49)
|
17.00 mm
Standard Deviation 3.32
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Middle VBH change (n=47)
|
0.94 mm
Standard Deviation 1.38
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Posterior VBH at intra-op with Bolster (n=47)
|
23.68 mm
Standard Deviation 3.85
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Posterior VBH at Intra-op 1st IBT (n=49)
|
24.05 mm
Standard Deviation 3.61
|
—
|
|
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Posterior VBH change (n=47)
|
0.37 mm
Standard Deviation 0.81
|
—
|
SECONDARY outcome
Timeframe: baseline and intra-operativePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Anterior VBH at baseline (n=54, 53)
|
14.15 mm
Standard Deviation 5.25
|
14.27 mm
Standard Deviation 5.02
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Anterior VBH at intra-op with Bolster (n=50, 47)
|
16.93 mm
Standard Deviation 4.99
|
17.03 mm
Standard Deviation 4.72
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Anterior VBH gained (n=47, 46)
|
2.96 mm
Standard Deviation 3.55
|
3.05 mm
Standard Deviation 3.21
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Middle VBH at baseline (n=54, 53)
|
13.98 mm
Standard Deviation 4.12
|
14.21 mm
Standard Deviation 4.07
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Middle VBH at intra-op with Bolster (n=50, 47)
|
15.96 mm
Standard Deviation 4.36
|
15.99 mm
Standard Deviation 3.60
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Middle VBH gained (n=47, 46)
|
1.88 mm
Standard Deviation 2.64
|
2.14 mm
Standard Deviation 2.48
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Posterior VBH at baseline (n=54, 53)
|
22.79 mm
Standard Deviation 3.61
|
22.94 mm
Standard Deviation 4.32
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Posterior VBH at Intra-op with Bolser (n=50, 47)
|
23.41 mm
Standard Deviation 4.02
|
23.68 mm
Standard Deviation 3.85
|
|
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Posterior VBH gained (47, 46)
|
0.64 mm
Standard Deviation 1.69
|
0.95 mm
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline and 48 hr post-procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
VBA at baseline (n=54, 53)
|
-15.5 degree
Standard Deviation 7.17
|
-15.1 degree
Standard Deviation 7.82
|
|
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
VBA at 48 hr post-procedure (n=56, 51)
|
-12.4 degree
Standard Deviation 6.23
|
-11.5 degree
Standard Deviation 6.84
|
|
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
Angle change (n=53, 50)
|
2.88 degree
Standard Deviation 4.48
|
3.00 degree
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: baseline and 48 hr post-procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Deformity Correction Assessed by Local Cobb Angle (LCA)
LCA at Baseline (n=53, 50)
|
-13.8 degree
Standard Deviation 15.09
|
-11.5 degree
Standard Deviation 17.82
|
|
Deformity Correction Assessed by Local Cobb Angle (LCA)
LCA at 48 hr post-procedure (n=56, 49)
|
-10.70 degree
Standard Deviation 16.28
|
-7.88 degree
Standard Deviation 16.29
|
|
Deformity Correction Assessed by Local Cobb Angle (LCA)
Angle change (n=52, 48)
|
1.36 degree
Standard Deviation 3.68
|
1.87 degree
Standard Deviation 3.63
|
SECONDARY outcome
Timeframe: Baseline and 48 hr post-procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Change in Back Pain.
Back pain change from baseline (n=57, 55)
|
-4.7 units on a scale
Standard Deviation 1.9
|
-4.2 units on a scale
Standard Deviation 1.9
|
|
Change in Back Pain.
Back pain at baseline (n=57, 55)
|
7.7 units on a scale
Standard Deviation 1.3
|
7.5 units on a scale
Standard Deviation 1.3
|
|
Change in Back Pain.
Back pain at 48 hr post-procedure (n=57, 55)
|
3.0 units on a scale
Standard Deviation 2.0
|
3.3 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 48 hrs post-procedurePopulation: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
Ambulatory status was assessed by subjective patient questionnaire.
Outcome measures
| Measure |
Curette-First
n=57 Participants
Use of curette prior to use of inflatable bone tamps
|
IBT-First
n=55 Participants
Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
|
|---|---|---|
|
Change in Ambulatory Status
Able to walk without assistance -- baseline
|
36 participants
|
34 participants
|
|
Change in Ambulatory Status
Able to walk with aid -- baseline
|
18 participants
|
21 participants
|
|
Change in Ambulatory Status
Must use wheelchair or bedridden -- baseline
|
3 participants
|
0 participants
|
|
Change in Ambulatory Status
Able to walk without assistance -- 48 hrs post-op
|
48 participants
|
42 participants
|
|
Change in Ambulatory Status
Able to walk with aid -- 48 hrs post-op
|
9 participants
|
12 participants
|
|
Change in Ambulatory Status
Must use wheelchair or bedridden -- 48 hrs post-op
|
0 participants
|
1 participants
|
|
Change in Ambulatory Status
No change
|
43 participants
|
40 participants
|
|
Change in Ambulatory Status
Improved
|
13 participants
|
11 participants
|
|
Change in Ambulatory Status
Worsened
|
1 participants
|
4 participants
|
Adverse Events
Curette-First
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
IBT-First
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Curette-First
n=57 participants at risk
Use of the curette prior to use of the inflatable bone tamps
|
IBT-First
n=55 participants at risk
Use of the inflatable bone tamps prior to using the curette
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Post procedural pneumonia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Septic shock
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.8%
1/57 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/57
|
3.6%
2/55 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Psychiatric decompensation
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
Other adverse events
| Measure |
Curette-First
n=57 participants at risk
Use of the curette prior to use of the inflatable bone tamps
|
IBT-First
n=55 participants at risk
Use of the inflatable bone tamps prior to using the curette
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Procedural vomiting
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Adverse drug reaction
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site pain
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Nervous system disorders
Confusion postoperative
|
3.5%
2/57 • Number of events 2
|
0.00%
0/55
|
|
Nervous system disorders
Headache
|
3.5%
2/57 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/57 • Number of events 1
|
0.00%
0/55
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/57
|
1.8%
1/55 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60