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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curette-First | Active Comparator | All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps. |
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| IBT-First | Active Comparator | All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kyphon® Curette | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Baseline and 48-hr post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 48 hours after procedure |
| Amount of Vertebral Body Height (VBH) Gained From IBTs Alone |
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Inclusion Criteria:
Age >= 50 years
One painful VCF meeting all of the following criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| George Fueredi, M.D. | Aurora Heath Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research and Education | Temple Terrace | Florida | 33637 | United States | ||
| Atrium Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23179647 | Derived | Bastian L, Schils F, Tillman JB, Fueredi G; SCORE Investigators. A randomized trial comparing 2 techniques of balloon kyphoplasty and curette use for obtaining vertebral body height restoration and angular-deformity correction in vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2013 Mar;34(3):666-75. doi: 10.3174/ajnr.A3363. Epub 2012 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Curette-First | Use of the curette prior to use of the inflatable bone tamps |
| FG001 | IBT-First | Use of the inflatable bone tamps prior to using the curette |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 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) | 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. | Baseline and 48 hr post-procedure |
| 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. | baseline and 48 hr post-procedure |
| Change in Back Pain. | Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain. | Baseline and 48 hr post-procedure |
| Change in Ambulatory Status | Ambulatory status was assessed by subjective patient questionnaire. | Baseline and 48 hrs post-procedure |
| Middletown |
| Ohio |
| 45005 |
| United States |
| Aurora Medical Group, Memorial Hospital of Burlington | Burlington | Wisconsin | 53105 | United States |
| CHC - Les Cliniques Saint-Joseph | Liège | 4000 | Belgium |
| St. Augustinus ziekenhuis | Wilrijk | 2610 | Belgium |
| Charité Campus Virchow-Klinikum Berlin | Berlin | 13353 | Germany |
| Kliniken im Naturpark Altmühltal | Eichstätt | 85072 | Germany |
| Klinikum Kempten | Kempten | 87439 | Germany |
| Klinikum Leverkusen gGmbH | Leverkusen | 51375 | Germany |
| Paracelcus-Klinik München | München | 81679 | Germany |
| Kliniken Dr. Erler | Nuremberg | 90429 | Germany |
| Krankenhaus Barmherzige Bruder Regensburg | Regensburg | 93049 | Germany |
| Asklepios Orthopadische Klinik Lindenlohe | Schwandorf in Bayern | 92421 | Germany |
| FG002 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Curette-First | Use of the curette prior to use of the inflatable bone tamps |
| BG001 | IBT-First | Use of the inflatable bone tamps prior to using the curette |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Smoking history | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment | Posted | Mean | Standard Deviation | percent change | Baseline and 48-hr post-procedure |
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| 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. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Median | Standard Deviation | mm | Baseline and 48 hours after procedure |
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| 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. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Mean | Standard Deviation | mm | Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation. |
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| Secondary | Amount of Vertebra Body Height (VBH) Gained by Postural Reduction | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Mean | Standard Deviation | mm | baseline and intra-operative |
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| 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. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Mean | Standard Deviation | degree | Baseline and 48 hr post-procedure |
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| 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. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Mean | Standard Deviation | degree | baseline and 48 hr post-procedure |
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| Secondary | Change in Back Pain. | Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 hr post-procedure |
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| Secondary | Change in Ambulatory Status | Ambulatory status was assessed by subjective patient questionnaire. | Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment. | Posted | Number | participants | Baseline and 48 hrs post-procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Curette-First | Use of the curette prior to use of the inflatable bone tamps | 5 | 57 | 12 | 57 | ||
| EG001 | IBT-First | Use of the inflatable bone tamps prior to using the curette | 8 | 55 | 11 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | medDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
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| Septic shock | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Psychiatric decompensation | Psychiatric disorders | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Procedural vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Adverse drug reaction | General disorders | Systematic Assessment |
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| Helicobacter gastritis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Confusion postoperative | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Tillman | Medtronic | 408-548-6518 | tillmj1@mspexcng.medtronic.com |
| Male |
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| Hispanic |
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| Middle Eastern |
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| Belgium |
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| Germany |
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| Current Smoker |
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| Former Smoker |
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| Posterior vertebral measurement (n=52, 50) |
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| t-test, 2 sided |
| 0.643 |
| Superiority or Other |
| Posterior vertebral body height restoration as a percent (Post-procedure change from baseline) | t-test, 2 sided | 0.165 | Superiority or Other |
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