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Clinical Trials: A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) device in healthy adults suffering from at least 6 months of moderate spinal stenosis sympt

 


A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) device in healthy adults suffering from at least 6 months of moderate spinal stenosis sympt


Trial Focus

Trial Focus

Back, Neck, and Spine

Objective

        
Patients diagnosed with lumbar spinal stenosis may be eligible to participate in a clinical trial under the supervision of The University of Colorado Hospital spine surgeons.
The study examines the effectiveness of the SuperionTM Interspinous Spacer Device as a potential alterative to traditional spinal surgery. The device is designed to relieve leg, buttock and groin pain resulting from pressure on the spinal nerve roots.
The device is implanted through a small skin incision and may be less invasive than traditional spinal surgery, with a faster recovery time.

IRB Protocol #

08-0743

Trial Status

In Progress

Contact

The Spine Center at 720-848-1980

Eligibility and Other Participant Information


Eligibility
To qualify, participants must:
•Be diagnosed with lumbar spinal stenosis
•Have undergone non-operative treatment for unrelieved symptoms for at least 6 months
•Be over 45 years of age
•Have leg, buttock or groin pain that is relieved by sitting or bending forward
•Not have a history of prior surgery to the lower spine
Other qualifications apply.