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

Primary Purpose

Vertebral Body Compression Fractures (VCFs)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Kyphon® Curette
Sponsored by
Medtronic Spine LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Body Compression Fractures (VCFs)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation for Orthopaedic Research and Education
  • Atrium Medical Center
  • Aurora Medical Group, Memorial Hospital of Burlington
  • CHC - Les Cliniques Saint-Joseph
  • St. Augustinus ziekenhuis
  • Charité Campus Virchow-Klinikum Berlin
  • Kliniken im Naturpark Altmühltal
  • Klinikum Kempten
  • Klinikum Leverkusen gGmbH
  • Paracelcus-Klinik München
  • Kliniken Dr. Erler
  • Krankenhaus Barmherzige Bruder Regensburg
  • Asklepios Orthopadische Klinik Lindenlohe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Curette-First

IBT-First

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)

Secondary Outcome Measures

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.
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.
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
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.
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.
Change in Back Pain.
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Change in Ambulatory Status
Ambulatory status was assessed by subjective patient questionnaire.

Full Information

First Posted
December 12, 2008
Last Updated
December 6, 2017
Sponsor
Medtronic Spine LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00810043
Brief Title
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Acronym
MDTSCORE
Official Title
Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spine LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Body Compression Fractures (VCFs)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curette-First
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IBT-First
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kyphon® Curette
Intervention Description
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
Primary Outcome Measure Information:
Title
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Time Frame
Baseline and 48-hr post-procedure
Secondary Outcome Measure Information:
Title
Index Vertebral Body Height Restored in Millimeters.
Description
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
Title
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Description
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.
Title
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Time Frame
baseline and intra-operative
Title
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
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. 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
Title
Deformity Correction Assessed by Local Cobb Angle (LCA)
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. 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
Title
Change in Back Pain.
Description
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
Title
Change in Ambulatory Status
Description
Ambulatory status was assessed by subjective patient questionnaire.
Time Frame
Baseline and 48 hrs post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Fueredi, M.D.
Organizational Affiliation
Aurora Heath Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation for Orthopaedic Research and Education
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Atrium Medical Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Aurora Medical Group, Memorial Hospital of Burlington
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Facility Name
CHC - Les Cliniques Saint-Joseph
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
St. Augustinus ziekenhuis
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Charité Campus Virchow-Klinikum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Kliniken im Naturpark Altmühltal
City
Eichstätt
ZIP/Postal Code
85072
Country
Germany
Facility Name
Klinikum Kempten
City
Kempten
ZIP/Postal Code
87439
Country
Germany
Facility Name
Klinikum Leverkusen gGmbH
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Paracelcus-Klinik München
City
München
ZIP/Postal Code
81679
Country
Germany
Facility Name
Kliniken Dr. Erler
City
Nurnberg
ZIP/Postal Code
90429
Country
Germany
Facility Name
Krankenhaus Barmherzige Bruder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Asklepios Orthopadische Klinik Lindenlohe
City
Schwandorf
ZIP/Postal Code
92421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23179647
Citation
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.
Results Reference
derived

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

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