Clinical trial NCT00810043: Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Official title: Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vertebral Body Compression Fractures (VCFs)
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
timeFrame: Baseline and 48-hr post-procedure
Secondary outcomes:
measure: Index Vertebral Body Height Restored in Millimeters.
timeFrame: Baseline and 48 hours after procedure
measure: Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
timeFrame: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.
measure: Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
timeFrame: baseline and intra-operative
measure: Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
timeFrame: Baseline and 48 hr post-procedure
measure: Deformity Correction Assessed by Local Cobb Angle (LCA)
timeFrame: baseline and 48 hr post-procedure
measure: Change in Back Pain.
timeFrame: Baseline and 48 hr post-procedure
measure: Change in Ambulatory Status
timeFrame: Baseline and 48 hrs post-procedure
Other outcomes:
Locations:
city: Temple Terrace
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Middletown
country: United States
facility: Atrium Medical Center
state: Ohio
city: Burlington
country: United States
facility: Aurora Medical Group, Memorial Hospital of Burlington
state: Wisconsin
city: Liege
country: Belgium
facility: CHC - Les Cliniques Saint-Joseph
city: Wilrijk
country: Belgium
facility: St. Augustinus ziekenhuis
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum Berlin
city: Eichstätt
country: Germany
facility: Kliniken im Naturpark Altmühltal
city: Kempten
country: Germany
facility: Klinikum Kempten
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH
city: München
country: Germany
facility: Paracelcus-Klinik München
city: Nurnberg
country: Germany
facility: Kliniken Dr. Erler
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder Regensburg
city: Schwandorf
country: Germany
facility: Asklepios Orthopadische Klinik Lindenlohe
Study officials:
affiliation: Aurora Heath Care, Inc.
name: George Fueredi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.