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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 4  |  Page : 181-186

Post-market surveillance study of FLXfit TLIF interbody fusion device: protocol for a prospective case series study


Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA

Correspondence Address:
Kern Singh
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5658.196981

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Background: Minimally invasive (MIS) lumbar fusion is a frequently utilized treatment for lumbar degenerative pathology. Interbody cages have been the preferred fusion construct in these procedures due to their ability to facilitate fusion and provide structural stability. However, due to the anatomic small access corridor of minimally invasive lumbar fusion procedures, the interbody cages used in these techniques are often limited in size, increasing the risk for pseudarthrosis and subsidence. Expandable interbody cages have been developed to overcome these risks in limitations. However, few clinical studies have been developed and initiated to describe the fusion rates, clinical outcomes, and complication rates in patients receiving these expandable cages. Methods/Design: A prospective case series of 30 patients receiving the FLXFit expandable interbody cage device is currently underway. Patients to undergo MIS transforaminal lumbar interbody fusion (TLIF) for degenerative pathology will be recruited based on their meeting of inclusion criteria and eligibility to receive the expandable cage device. Patient follow-up will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years. The primary outcome will be fusion status at 1-year, as measured by computed tomography (CT) scan. Patient reported outcomes and radiographic measurements will be obtained preoperatively and at all postoperative time points. All complications, reoperations, and hospital readmissions occurring during follow up will also be recorded. Discussion: This protocol is designed to better describe the outcomes and complications following the utilization of the FLXFit expandable interbody cage device following MIS TLIF. The present manuscript provides the process for patient selection, intervention, and follow-up. Trial registration: ClinicalTrials.gov identifier NCT02805985; registered on June 15, 2016. Ethics: The study protocol has been approved by the Rush University Institutional Review Board (IRB), and will be performed under the ethical standards of the IRB. Informed consent: Signed informed consent will be obtained from each patient.


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