An option for your spinal stenosis patients

Over 25,000 patients outside the U.S. have received the coflex^® implant. Paradigm Spine, LLC, is now proceeeding with a prospective, randomized, multi-center clinical research study on the coflex.

A total of 460 patients will be enrolled in the investigations, of whom 280 will be randomized to receive the coflex implant, with an additional 40 subjects who will receive coflex as a non-randomized “roll-in” patient. With a 2:1 randomization ratio, eligible study subjects have an excellent chance of receiving the coflex implant over the control, which is pedicle screw fixation and fusion after decompression, the current standard of care.

Patients who meet the inclusion/exclusion criteria will be considered for enrollment into the trial. In addition to meeting the pre-screening criteria, and after obtaining informed consent, prospective patients will undergo additional tests and assessments to determine their eligibility for the trial:

• Preoperative history
• Clinical evaluation
• Patient self-assessments: VAS; Patient Survey; Oswestry Questionnaire; Zurich Claudication Questionnaire (symptom severity and physical function portions only); and SF-12 Health Survey
• Radiographic studies including flexion/extension; neutral lateral and AP; CT or MRI imaging (for confirmation of stenosis pathology) and a DEXA Scan if needed

Upon determination of eligibility, and after signing the consent form, patients will be randomized into either the Treatment Group or the Control Group.

Follow-up visits will occur at regularly scheduled times which will be coordinated with the study team that will be providing your care.

Subjects will be removed from the trial if they withdraw their consent or are withdrawn on the recommendation of their physician. Participation in the trial is completely voluntary and consent may be rescinded at any time.

For more information on the coflex clinical research study, or to see if you might be eligible to participate, call 1-866-493-9510 Mon–Thurs, 7am– 7pm and Fri, 7am– 6pm, CST.

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.