Non-fusion Spine Stabilization Device

Full Title of Study

Pivotal Study of the Coflex™: an Investigational Non-fusion Spine Stabilization Device (R#06-378)

Purpose of Study

To evaluate the safety and effectiveness of the Coflex device compared to a surgical control, posterolateral fusion with autograft bone and pedicle screw fixation, following decompressive laminectomy for the treatment of one or two level lumbar stenosis from L1-L5 that requires surgical decompression, and in patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of conservative treatment.

Basic Inclusion Criteria (requirements for being included in study)

  • Between 40 and 80 years of age
  • Have moderate to severe stenosis
  • Have undergone at least six (6) months of prior conservative care, including one (1) epidural injection, without adequate and sustained symptom relief

Basic Exclusion Criteria (reasons for being excluded from study)

  • You must not have had a spinal fusion in the past.
  • Your age, weight, or activity level would cause the surgeon to expect early failure of the system.
  • You are unwilling or unable to comply with the postoperative care instructions.
  • History of alcohol, drug, or other substance abuse.
  • History of cancer in past 5 years.
  • Any disease state that could adversely affect the function or longevity of the implant.

Study Visit Requirements

Patients are evaluated preoperatively, at the time of surgery, and at 6 weeks, 12 weeks, 6 months, 12 months, 18 months, and 24 months after surgery and annually thereafter.

Principal Investigator

Thomas Errico, MD

Answers to frequently asked questions (FAQs) about clinical trials

For more information about enrolling in this study, please contact Alexandra Lee, or 212-598-6114