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A 2-and-5-year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with or without additional stabilization using the coflex® ® Interlaminar Technology for FDA Actual Conditions of Use Study.

Primary Objective

To fully characterize safety and efficacy when the coflex® device is used in the intended subject population under the actual conditions of use”

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Description

The first objective addresses coflex® performance in actual conditions of use settings at two years and at five years relative to pivotal trial device performance. The second objective compares coflex® performance in actual conditions of use settings to decompression alone using data from the completed randomized ESCADA study comparing coflex® to decompression alone.

Details
Age
Adult
Eligibility
Radiographic confirmation of at least moderate lumbar stenosis, at one or two contiguous levels from L1-L5 that require surgical decompression.1.Radiographic confirmation of at least moderate lumbar stenosis, at one or two contiguous levels from L1-L5 that require surgical decompression. 2. VAS back pain score of at least 50 mm on a 100 mm scale. 3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair. 4. Subject has undergone at least one lumbar injection (as defined in Section 5.1 Primary Variables of Performance) at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief. 5. Skeletally mature. 6. Oswestry Low Back Pain Disability Questionnaire (ODI score of at least 20/50 (40%). 7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. 8. Personally, signed and dated informed consent document prior to any study-related procedures indicating that the subject has been informed of all pertinent aspects of the trial.
Locations

Highlands Ranch Hospital
University of Colorado Hospital

Principal Investigator
Photograph of Vikas Patel

Vikas Patel

Study ID

Protocol Number: 22-0695

Categories

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