Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
NCT ID: NCT00810043
Last Updated: 2017-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2009-02-28
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Curette-First
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.
Kyphon® 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
IBT-First
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.
Kyphon® 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
Interventions
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Kyphon® 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
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
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Medtronic Spine LLC
INDUSTRY
Responsible Party
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Principal Investigators
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George Fueredi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aurora Heath Care, Inc.
Locations
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Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, United States
Atrium Medical Center
Middletown, Ohio, United States
Aurora Medical Group, Memorial Hospital of Burlington
Burlington, Wisconsin, United States
CHC - Les Cliniques Saint-Joseph
Liège, , Belgium
St. Augustinus ziekenhuis
Wilrijk, , Belgium
Charité Campus Virchow-Klinikum Berlin
Berlin, , Germany
Kliniken im Naturpark Altmühltal
Eichstätt, , Germany
Klinikum Kempten
Kempten, , Germany
Klinikum Leverkusen gGmbH
Leverkusen, , Germany
Paracelcus-Klinik München
München, , Germany
Kliniken Dr. Erler
Nuremberg, , Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, , Germany
Asklepios Orthopadische Klinik Lindenlohe
Schwandorf in Bayern, , Germany
Countries
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References
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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.
Other Identifiers
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SP0801 - SCORE
Identifier Type: -
Identifier Source: org_study_id