DIAM Clinical Trial

Title: “A Prospective, Randomized, Controlled Pivotal Clinical Investigation of the DIAM™ Spinal Stabilization System in Patients with Lumbar Degenerative Disc Disease”

Study Sponsor: Medtronic Spinal and Biologics

Principal Investigator: Christopher Rumana, MD

Study Synopsis: To evaluate the DIAM™ Spinal Stabilization System (Medtronic Spinal and Biologics) for the treatment of patients with single-level moderate lumbar degenerative disc disease. This study will evaluate the safety and effectiveness of the DIAM™ Spinal Stabilization System as a method of treating patients with moderate lumbar degenerative disc disease at a single level from L2 to L5.

Patients enrolled in the trial will be randomized to receive either the DIAM™ device or the current standard of care treatment (physical therapy, prescription medications, and injection therapy). All study subjects will undergo clinical follow-up in-hospital (if randomized to DIAM™ device) and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after enrollment. This study will enroll a total of 306 people at 30 investigational sites.

Study Status: Open for enrollment. Who qualifies? Patients may qualify if their degenerative disc disease meets the study criteria.

For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.

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