NCT02684045CompletedNot Applicable
A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine
Medtronic Spinal and Biologics2 sites in 1 country76 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Fusion status at 12 or 24 months
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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-S
- •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
- •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.
Outcomes
Primary Outcomes
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
- Back pain and leg pain measured by visual analog scale (VAS)(12 or 24 months)
- Pain and Disability status measured by Oswestry Disability Index (ODI)(12 or 24 months)
- Quality of life measured by EQ-5D(12 or 24 months)
Investigators
Study Sites (2)
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