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OpenTrials
Completed

NCT Number: NCT02684045

Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine

The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.

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Key information

Conditions

Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwest Ortho. Center, Peoria, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

A subject's medical record must contain the following for the subject to be included:

  • Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
  • Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
  • Subject must be at least 18 years old at the time of index procedure.

Exclusion criteria

The subject data will be excluded from this study if the medical record indicates:

  • Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
  • Infection at index level(s) at time of surgery.
  • Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
  • Pregnant at time of surgery.
  • Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
  • Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery.
  • Procedure is a revision surgery for previously failed fusion at the surgery index level(s).
  • Subjects with body mass index > 40 at the time of surgery.

Treatment and study plan

Primary outcomes

  1. Fusion status at 12 or 24 months

    Time frame: 12 or 24 months

    Fusion status will be assessed using the Lenke posterior fusion criteria below:

    • Grade I: Solid trabeculated transverse process and facet fusions bilaterally.
    • Grade II: Thick fusion mass on one side, and difficult to visualize on the other side.
    • Grade III: Suspected lucency or defect in the fusion mass.
    • Grade IV: Definite resorption of graft with fatigue of instrumentation.

Secondary outcomes

  1. Back pain and leg pain measured by visual analog scale (VAS)

    Time frame: 12 or 24 months

  2. Pain and Disability status measured by Oswestry Disability Index (ODI)

    Time frame: 12 or 24 months

  3. Quality of life measured by EQ-5D

    Time frame: 12 or 24 months

Other outcomes

  1. complications of interest

    Time frame: 12 or 24 months

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Official study title

A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Aug 21, 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.