Claudication, Intermittent Clinical Trial
Official title:
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis: A Single Arm, Prospective, Mutli-Center Study
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
After being informed about the study and potential risks, patients with Lumbar Spinal Stenosis matching inclusion and exclusion criteria giving written informed consent will undergo Lobster device implantation and followed-up for 2 years for radiological and clinical assessment in a single-arm, prospective, multicentric clinical trial. ;
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