Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

Conditions
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Vertebral Body Compression Fractures (VCFs)

Intervention / Treatment
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* Device: Kyphon® Curette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curette-First<br>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. | Device: Kyphon® Curette<br>* 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<br>|
| Active Comparator: IBT-First<br>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. | Device: Kyphon® Curette<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) |  | Baseline and 48-hr post-procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |