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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00810043
First received: December 12, 2008
Last updated: April 3, 2014
Last verified: April 2014
  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 4

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:


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: Baseline and 48-hr post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Index Vertebral Body Height Restored in Millimeters. [ Time Frame: Baseline and 48 hours after procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation. ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and intra-operative ] [ Designated as safety issue: No ]
  • Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) [ Time Frame: Baseline and 48 hr post-procedure ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and 48 hr post-procedure ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 48 hr post-procedure ] [ Designated as safety issue: No ]
    Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.

  • Change in Ambulatory Status [ Time Frame: Baseline and 48 hrs post-procedure ] [ Designated as safety issue: No ]
    Ambulatory status was assessed by subjective patient questionnaire.


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
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
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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Medtronic Spine LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 3, 2014
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 September 16, 2014