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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Vertebral Body Compression Fractures (VCFs)

Treatments: Device: Kyphon® Curette

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810043

SP0801 - SCORE

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Curette-First

Active Comparator group

Description:

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.

Treatment:

Device: Kyphon® Curette

IBT-First

Active Comparator group

Description:

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.

Treatment:

Device: Kyphon® Curette