To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.
The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels in the region of L1 - L5. The height of the neuroforamen is maintained and the facet joints will be relieved. By this a further destruction is prevented. Unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected. Possible risks, which could occur after implantation of the coflex® Interlaminar Technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy. In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® Interlaminar Technology during normal conditions of use. This data will provide evidence to support publications and marketing.
Study Type
OBSERVATIONAL
Enrollment
5,050
Interlaminer Technology
Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
Time frame: Study Duration Up to 6 months for data collection
Overall Incidence of Secondary Surgical Interventions Post Surgeries.
To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.
Time frame: Study Duration up to 6 months data
The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.
To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device. The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.
Time frame: Study Duration Up to 6 months for data collection
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