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Completed

NCT Number: NCT00810043

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

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.

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Key information

Conditions

Vertebral Body Compression Fractures (VCFs)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHC - Les Cliniques Saint-Joseph, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kyphon® Curette

Device

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

Primary outcomes

  1. Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)

    Time frame: Baseline and 48-hr post-procedure

Secondary outcomes

  1. Index Vertebral Body Height Restored in Millimeters.

    Time frame: Baseline and 48 hours after procedure

    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.

  2. 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.

    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.

  3. Amount of Vertebra Body Height (VBH) Gained by Postural Reduction

    Time frame: baseline and intra-operative

  4. Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)

    Time frame: Baseline and 48 hr post-procedure

    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.

  5. Deformity Correction Assessed by Local Cobb Angle (LCA)

    Time frame: baseline and 48 hr post-procedure

    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.

  6. Change in Back Pain.

    Time frame: Baseline and 48 hr post-procedure

    Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.

  7. Change in Ambulatory Status

    Time frame: Baseline and 48 hrs post-procedure

    Ambulatory status was assessed by subjective patient questionnaire.

Sponsors and collaborators

Lead sponsor

Medtronic Spine LLC

Industry

Registry information

Official study title

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

Acronym: MDTSCORE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2008
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.