Vertebral Body Compression Fractures (VCFs)
Conditions
Brief summary
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
Interventions
DEVICEKyphon® Curette
The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
Sponsors
Medtronic Spine LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 50 years * One painful VCF meeting all of the following criteria: * Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis * VCF is between T5 and L5 * VCF shows hyperintense signal on STIR or T2 weighted MRI * VCF has at least 15% height loss as visualized on plain radiograph * Identified painful VCF has at least superior and one normal vertebrae within 2 levels inferior. * Either the immediate superior OR the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment. * Patient states availability for all study visits * Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
Exclusion criteria
* Patient is unable to undergo MRI * Patient shows evidence of edema in vertebral bodies other than index level on MRI * Patient is unable to stand for pre-operative and post-operative x-rays * Patient body mass index (BMI) is greater than 35 kg/m2 * Patient is pregnant, or of child-bearing potential and not using contraception * Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF * Index fracture is result of high-energy trauma * Suspected or proven cancer inside any VB * Disabling back pain due to causes other than acute fracture * Spine stabilization beyond balloon kyphoplasty required for index VCF * Pre-existing conditions contrary to balloon kyphoplasty, such as: * Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants. * Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used. * Any evidence of VB or systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Baseline and 48-hr post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Vertebral Body Height (VBH) Gained From IBTs Alone | Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation. | 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. |
| Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | baseline and intra-operative | — |
| Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | Baseline and 48 hr post-procedure | 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. |
| Index Vertebral Body Height Restored in Millimeters. | Baseline and 48 hours after procedure | 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. |
| Change in Back Pain. | Baseline and 48 hr post-procedure | Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain. |
| Change in Ambulatory Status | Baseline and 48 hrs post-procedure | Ambulatory status was assessed by subjective patient questionnaire. |
| Deformity Correction Assessed by Local Cobb Angle (LCA) | baseline and 48 hr post-procedure | 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. |
Countries
Belgium, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Curette-First Use of the curette prior to use of the inflatable bone tamps | 57 |
| IBT-First Use of the inflatable bone tamps prior to using the curette | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | No longer met enrollment criteria | 0 | 0 | 3 |
| Overall Study | Non-medical problem | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 2 |
| Overall Study | Unrelated medical problem | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Curette-First | IBT-First | Total |
|---|---|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 8.4 | 76.0 years STANDARD_DEVIATION 9.4 | 74.8 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Caucasian | 55 participants | 55 participants | 110 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Middle Eastern | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Belgium | 18 participants | 16 participants | 34 participants |
| Region of Enrollment Germany | 26 participants | 21 participants | 47 participants |
| Region of Enrollment United States | 13 participants | 18 participants | 31 participants |
| Sex: Female, Male Female | 47 Participants | 41 Participants | 88 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
| Smoking history Current Smoker | 7 Participants | 5 Participants | 12 Participants |
| Smoking history Former Smoker | 14 Participants | 14 Participants | 28 Participants |
| Smoking history Never Smoked | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 57 | 11 / 55 |
| serious Total, serious adverse events | 5 / 57 | 8 / 55 |
Outcome results
Primary
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Time frame: Baseline and 48-hr post-procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | 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 |
| Curette-First | 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 |
| Curette-First | 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 |
| IBT-First | Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Anterior vertebral measurement (n=52, 50) | 11.77 percent change | Standard Deviation 13.23 |
| IBT-First | Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Mid-vertebral measurement (n=52, 50) | 9.07 percent change | Standard Deviation 10.31 |
| IBT-First | Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Posterior vertebral measurement (n=52, 50) | 4.21 percent change | Standard Deviation 6.49 |
Comparison: Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)p-value: 0.43t-test, 2 sided
Comparison: Middle vertebral body height restoration as a percent (Post-procedure change from baseline)p-value: 0.643t-test, 2 sided
Comparison: Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)p-value: 0.165t-test, 2 sided
Secondary
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Time frame: baseline and intra-operative
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | 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 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Middle VBH gained (n=47, 46) | 1.88 mm | Standard Deviation 2.64 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Middle VBH at baseline (n=54, 53) | 13.98 mm | Standard Deviation 4.12 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Posterior VBH at baseline (n=54, 53) | 22.79 mm | Standard Deviation 3.61 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Anterior VBH gained (n=47, 46) | 2.96 mm | Standard Deviation 3.55 |
| Curette-First | 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 |
| Curette-First | 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 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Posterior VBH gained (47, 46) | 0.64 mm | Standard Deviation 1.69 |
| Curette-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Anterior VBH at baseline (n=54, 53) | 14.15 mm | Standard Deviation 5.25 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Posterior VBH gained (47, 46) | 0.95 mm | Standard Deviation 1.53 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Anterior VBH at baseline (n=54, 53) | 14.27 mm | Standard Deviation 5.02 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Anterior VBH at intra-op with Bolster (n=50, 47) | 17.03 mm | Standard Deviation 4.72 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Anterior VBH gained (n=47, 46) | 3.05 mm | Standard Deviation 3.21 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Middle VBH at baseline (n=54, 53) | 14.21 mm | Standard Deviation 4.07 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Middle VBH at intra-op with Bolster (n=50, 47) | 15.99 mm | Standard Deviation 3.6 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Middle VBH gained (n=47, 46) | 2.14 mm | Standard Deviation 2.48 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Posterior VBH at baseline (n=54, 53) | 22.94 mm | Standard Deviation 4.32 |
| IBT-First | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Posterior VBH at Intra-op with Bolser (n=50, 47) | 23.68 mm | Standard Deviation 3.85 |
Comparison: Anterior VBH gained by postural reductionp-value: 0.9t-test, 2 sided
Comparison: Middle VBH gained by postural reductionp-value: 0.62t-test, 2 sided
Comparison: Posterior VBH gained by postural reductionp-value: 0.349t-test, 2 sided
Secondary
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | 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 |
| Curette-First | 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 |
| Curette-First | Amount of Vertebral Body Height (VBH) Gained From IBTs Alone | Anterior VBH change (n=47) | 1.25 mm | Standard Deviation 1.94 |
| Curette-First | Amount of Vertebral Body Height (VBH) Gained From IBTs Alone | Middle VBH at intra-op with Bolster (n=47) | 15.99 mm | Standard Deviation 3.6 |
| Curette-First | 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 |
| Curette-First | Amount of Vertebral Body Height (VBH) Gained From IBTs Alone | Middle VBH change (n=47) | 0.94 mm | Standard Deviation 1.38 |
| Curette-First | 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 |
| Curette-First | 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 |
| Curette-First | Amount of Vertebral Body Height (VBH) Gained From IBTs Alone | Posterior VBH change (n=47) | 0.37 mm | Standard Deviation 0.81 |
Secondary
Change in Ambulatory Status
Ambulatory status was assessed by subjective patient questionnaire.
Time frame: Baseline and 48 hrs post-procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Curette-First | Change in Ambulatory Status | No change | 43 participants |
| Curette-First | Change in Ambulatory Status | Able to walk without assistance -- baseline | 36 participants |
| Curette-First | Change in Ambulatory Status | Able to walk with aid -- baseline | 18 participants |
| Curette-First | Change in Ambulatory Status | Must use wheelchair or bedridden -- baseline | 3 participants |
| Curette-First | Change in Ambulatory Status | Able to walk without assistance -- 48 hrs post-op | 48 participants |
| Curette-First | Change in Ambulatory Status | Able to walk with aid -- 48 hrs post-op | 9 participants |
| Curette-First | Change in Ambulatory Status | Must use wheelchair or bedridden -- 48 hrs post-op | 0 participants |
| Curette-First | Change in Ambulatory Status | Improved | 13 participants |
| Curette-First | Change in Ambulatory Status | Worsened | 1 participants |
| IBT-First | Change in Ambulatory Status | Worsened | 4 participants |
| IBT-First | Change in Ambulatory Status | Able to walk with aid -- 48 hrs post-op | 12 participants |
| IBT-First | Change in Ambulatory Status | Able to walk without assistance -- baseline | 34 participants |
| IBT-First | Change in Ambulatory Status | Improved | 11 participants |
| IBT-First | Change in Ambulatory Status | Able to walk with aid -- baseline | 21 participants |
| IBT-First | Change in Ambulatory Status | Must use wheelchair or bedridden -- 48 hrs post-op | 1 participants |
| IBT-First | Change in Ambulatory Status | Must use wheelchair or bedridden -- baseline | 0 participants |
| IBT-First | Change in Ambulatory Status | No change | 40 participants |
| IBT-First | Change in Ambulatory Status | Able to walk without assistance -- 48 hrs post-op | 42 participants |
p-value: 0.36Chi-squared
Secondary
Change in Back Pain.
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Time frame: Baseline and 48 hr post-procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | Change in Back Pain. | Back pain at baseline (n=57, 55) | 7.7 units on a scale | Standard Deviation 1.3 |
| Curette-First | Change in Back Pain. | Back pain at 48 hr post-procedure (n=57, 55) | 3.0 units on a scale | Standard Deviation 2 |
| Curette-First | Change in Back Pain. | Back pain change from baseline (n=57, 55) | -4.7 units on a scale | Standard Deviation 1.9 |
| IBT-First | Change in Back Pain. | Back pain at baseline (n=57, 55) | 7.5 units on a scale | Standard Deviation 1.3 |
| IBT-First | Change in Back Pain. | Back pain at 48 hr post-procedure (n=57, 55) | 3.3 units on a scale | Standard Deviation 1.9 |
| IBT-First | Change in Back Pain. | Back pain change from baseline (n=57, 55) | -4.2 units on a scale | Standard Deviation 1.9 |
p-value: 0.144t-test, 2 sided
Secondary
Deformity Correction Assessed by Local Cobb Angle (LCA)
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.
Time frame: baseline and 48 hr post-procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | LCA at Baseline (n=53, 50) | -13.8 degree | Standard Deviation 15.09 |
| Curette-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | LCA at 48 hr post-procedure (n=56, 49) | -10.70 degree | Standard Deviation 16.28 |
| Curette-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | Angle change (n=52, 48) | 1.36 degree | Standard Deviation 3.68 |
| IBT-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | LCA at Baseline (n=53, 50) | -11.5 degree | Standard Deviation 17.82 |
| IBT-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | LCA at 48 hr post-procedure (n=56, 49) | -7.88 degree | Standard Deviation 16.29 |
| IBT-First | Deformity Correction Assessed by Local Cobb Angle (LCA) | Angle change (n=52, 48) | 1.87 degree | Standard Deviation 3.63 |
p-value: 0.486t-test, 2 sided
Secondary
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
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.
Time frame: Baseline and 48 hr post-procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | VBA at baseline (n=54, 53) | -15.5 degree | Standard Deviation 7.17 |
| Curette-First | 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 |
| Curette-First | Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | Angle change (n=53, 50) | 2.88 degree | Standard Deviation 4.48 |
| IBT-First | Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | VBA at baseline (n=54, 53) | -15.1 degree | Standard Deviation 7.82 |
| IBT-First | Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | VBA at 48 hr post-procedure (n=56, 51) | -11.5 degree | Standard Deviation 6.84 |
| IBT-First | Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) | Angle change (n=53, 50) | 3.00 degree | Standard Deviation 4.42 |
p-value: 0.889t-test, 2 sided
Secondary
Index Vertebral Body Height Restored in Millimeters.
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.
Time frame: Baseline and 48 hours after procedure
Population: Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Anterior VBH at 48 hr post-procedure (n=56, 51) | 16.65 mm | Standard Deviation 4.75 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint change in VBH (n=53, 50) | 1.98 mm | Standard Deviation 2.38 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint VBH at baseline (n=54, 53) | 13.98 mm | Standard Deviation 4.12 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Posterior VBH at baseline (n=54, 53) | 22.79 mm | Standard Deviation 3.61 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Anterior change in VBH (n=53, 50) | 2.28 mm | Standard Deviation 2.89 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Posterior VBH at 48 hr post-procedure (n=56, 51) | 23.57 mm | Standard Deviation 3.99 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint VBH at 48 hr post-procedure (n=56, 51) | 16.22 mm | Standard Deviation 4.01 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Posterior change in VBH (n=53, 50) | 0.65 mm | Standard Deviation 1.29 |
| Curette-First | Index Vertebral Body Height Restored in Millimeters. | Anterior VBH at baseline (n=54, 53) | 14.15 mm | Standard Deviation 5.25 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Posterior change in VBH (n=53, 50) | 1.05 mm | Standard Deviation 1.65 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Anterior VBH at baseline (n=54, 53) | 14.27 mm | Standard Deviation 5.02 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Anterior VBH at 48 hr post-procedure (n=56, 51) | 17.32 mm | Standard Deviation 4.33 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Anterior change in VBH (n=53, 50) | 2.78 mm | Standard Deviation 3.11 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint VBH at baseline (n=54, 53) | 14.21 mm | Standard Deviation 4.07 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint VBH at 48 hr post-procedure (n=56, 51) | 16.62 mm | Standard Deviation 3.39 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Midpoint change in VBH (n=53, 50) | 2.25 mm | Standard Deviation 2.58 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Posterior VBH at baseline (n=54, 53) | 22.94 mm | Standard Deviation 4.32 |
| IBT-First | Index Vertebral Body Height Restored in Millimeters. | Posterior VBH at 48 hr post-procedure (n=56, 51) | 24.02 mm | Standard Deviation 3.59 |
Comparison: Anterior VBH restoredp-value: 0.402t-test, 2 sided
Comparison: Middle VBH restoredp-value: 0.578t-test, 2 sided
Comparison: Posterior VBH restoredp-value: 0.166t-test, 2 sided