Status:
COMPLETED
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Lead Sponsor:
Medtronic Spine LLC
Conditions:
Vertebral Body Compression Fractures (VCFs)
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00810043
Start Date
February 1 2009
End Date
October 1 2010
Last Update
December 8 2017
Active Locations (13)
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1
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, United States, 33637
2
Atrium Medical Center
Middletown, Ohio, United States, 45005
3
Aurora Medical Group, Memorial Hospital of Burlington
Burlington, Wisconsin, United States, 53105
4
CHC - Les Cliniques Saint-Joseph
Liège, Belgium, 4000