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

Completed · Phase 4

Conditions studied: Vertebral Body Compression Fractures (VCFs)

In brief

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.

Key facts

Study ID

NCT00810043

Run by

Medtronic Spine LLC

People needed

120

Starts

2009-02-01

Expected to finish

2010-10-01

Last updated by the study team

2017-12-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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