Last updated on March 2020

Rampart Duo Clinical (RaDical) Post-Market Study

Brief description of study

This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation will be conducted at up to a maximum of 20 investigation centers with no more than 200 study subjects being enrolled. Data is being collected for patients undergoing a standard of care, on-label, lateral lumbar interbody fusion. The data collected in this evaluation will be used for publication and presentation.

Detailed Study Description

The purpose of this study is to collect data that reports on the clinical outcomes of patients treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels. Data is collected prospectively at specified time points per protocol and includes both objective and subjective measures. Patients will be followed to a maximum of two years.

Clinical Study Identifier: NCT03974711

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Spine Institute of Louisiana

Shreveport, LA United States
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Recruitment Status: Open

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