Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine
Completed
Conditions studied: Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine
In brief
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.
Key facts
- Study ID
- NCT02684045
- Run by
- Medtronic Spinal and Biologics
- People needed
- 76
- Starts
- 2017-03-01
- Expected to finish
- 2017-08-15
- Last updated by the study team
- 2017-08-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Midwest Ortho. Center — Peoria, Illinois, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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