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

Sponsor:	Medtronic Spine LLC
Information provided by (Responsible Party):	Medtronic Spine LLC
ClinicalTrials.gov Identifier:	NCT00810043

Purpose

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.

Condition	Intervention	Phase
Vertebral Body Compression Fractures (VCFs)	Device: Kyphon® Curette	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

Resource links provided by NLM:

MedlinePlus related topics: Anatomy Fractures

U.S. FDA Resources

Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:

Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) [ Time Frame: 48-hr post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess Angular Deformity Correction Using VBA, Local LCA, Amount of Height Gained by Postural Reduction, Amount of Height Gained From IBTs Alone (in the "IBT First" Arm Only) and Immediate Pain Relief Using a Patient Reported NRS [ Time Frame: 48 hours after procedure ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	February 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Curette-First Use of the curette prior to use of inflatable bone tamps	Device: 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
Active Comparator: IBT-First Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps	Device: 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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810043

Locations

United States, Florida
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, United States, 33637
United States, Ohio
Atrium Medical Center
Middletown, Ohio, United States, 45005
United States, Wisconsin
Aurora Medical Group, Memorial Hospital of Burlington
Burlington, Wisconsin, United States, 53105
Belgium
CHC - Les Cliniques Saint-Joseph
Liege, Belgium, 4000
St. Augustinus ziekenhuis
Wilrijk, Belgium, 2610
Germany
Charité Campus Virchow-Klinikum Berlin
Berlin, Germany, 13353
Kliniken im Naturpark Altmühltal
Eichstätt, Germany, 85072
Klinikum Kempten
Kempten, Germany, 87439
Klinikum Leverkusen gGmbH
Leverkusen, Germany, 51375
Paracelcus-Klinik München
München, Germany, 81679
Kliniken Dr. Erler
Nurnberg, Germany, 90429
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Asklepios Orthopadische Klinik Lindenlohe
Schwandorf, Germany, 92421

Sponsors and Collaborators

Medtronic Spine LLC

Investigators

Principal Investigator:

George Fueredi, M.D.

Aurora Heath Care, Inc.

More Information

No publications provided

Responsible Party:	Medtronic Spine LLC
ClinicalTrials.gov Identifier:	NCT00810043 History of Changes
Other Study ID Numbers:	SP0801 - SCORE
Study First Received:	December 12, 2008
Results First Received:	October 26, 2011
Last Updated:	October 26, 2011
Health Authority:	United States: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Fractures, Compression
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012