Clinical Research Directory

Combined Analysis of Retrospective and Prospective Data From Patients Who Underwent Facet Arthroplasty With the TOPS™ System or the TOPS + Versalink™ Fixation System at a Single Center.

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Summary

The TOPS™ system is an alternative to spinal fusion designed to stabilize-rather than fuse-the affected vertebral level, thereby relieving pain caused by degenerative spondylolisthesis and spinal stenosis. Degenerative spondylolisthesis involves abnormal, excessive vertebral movement, resulting in lower back and leg pain. Spinal stenosis is a condition in which nerve compression causes symptoms such as pain, numbness, and tingling in the legs. The TOPS system is intended to provide stabilization for skeletally mature patients with single-level disease (L3-L5) who have not achieved sufficient symptom relief through prior conservative care. The Total Posterior Spine System ("TOPS™ system") received CE marking and has been commercially available since 2012; it also received US FDA approval in June 2023. The Versalink™ fixation system is a bilateral titanium lumbar fusion system designed for use with a titanium cross-link as a standalone fusion device. It is also designed to connect above or below the TOPS™ device to form a hybrid construct. The TOPS system is designed to restore lumbar spine stability while allowing for spinal canal decompression (laminectomy/facetectomy). By using the TOPS™ system, the surgeon can remove pathological bony elements and implant a posterior spine replacement technology that effectively recreates load-bearing dynamics and spinal biomechanics, thereby preserving mobility in the treated segment.

Key Details

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Interventions

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