Who is the sponsor?

Paradigm Spine, LLC

What is the purpose and design of the study?

The purpose is to evaluate the safety and effectiveness of the coflex device compared to the control for purposes of a Premarket Approval (PMA) application to the FDA.

It is a multicenter, prospective, randomized, concurrently controlled study comparing stabilization with coflex versus pedicle screw fixation and fusion after decompression, the current standard of care, for at least moderate lumbar spinal stenosis.

What is the name of the device?

The name of the device is the coflex Interspinous Stabilization Device (“coflex”).

What is the indication for the device?

The coflex is an interspinous stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 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 six (6) months of conservative treatment.

What is the intended use for the device?

The coflex is intended to be implanted between the spinous processes of one or two contiguous lumbar motion segments. Interspinous stabilization is performed after decompression of stenosis at the affected level(s).

Where is the study taking place?

There will be 20 study sites in the United States.

What is the size and duration of the study?

A total of 460: 420 randomized patients (280 coflex and 140 control), plus 40 nonrandomized “roll-in” patients. The expected duration will be 24 months, with 5 year follow-up data collected.

Who can I speak to for more information
on the study?

For more information, please send an email to:

What are the Inclusions and Exclusions
for the study?

Inclusions:

• 40-80 years old
• Radiographic confirmation of at least moderate
  lumbar stenosis
• Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair
• Have undergone at least six (6) months of prior conservative care, including a minimum of at least one epidural injection, without adequate and sustained symptom relie
• Oswestry Low Back Pain Disability Questionnaire
  score of at least 20/50 (40%)
• Appropriate candidate for treatment using
  posterior surgical approach
• Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial

Exclusions:

• More than two (2) vertebral levels requiring
  surgical decompression
• Prior fusion or decompressive complete laminectomy,
  at any lumbar level
• Radiographically compromised vertebral bodies at any
  lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture)
• Severe facet hypertrophy that requires extensive bone
  removal which would cause instability
• Isthmic spondylolisthesis or spondylolysis (pars fracture)
• Degenerative lumbar scoliosis (Cobb angle of >25°)
• Disc herniation at any lumbar level requiring
  surgical intervention
• Back or leg pain of unknown etiology
• Axial back pain only, with no leg, buttock, or groin pain
• Morbid obesity defined as a body mass index > 40
• Pregnant or interested in becoming pregnant
  in the next three years
• Known allergy to titanium, titanium alloys,
  or MR contrast agents.
• Active or chronic infection – systemic or local
• Chronically taking medications or any drug known to
  potentially interfere with bone/soft tissue healing (e.g., steroids, not including a Medrol dose pack)
• Unremitting back pain in any position
• Uncontrolled diabetes
• Rheumatoid arthritis or other autoimmune diseases
• No known or documented history of communicable disease,
  including AIDS, HIV, active Hepatitis
• Prisoner or ward of the state
• Subject has a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
• Subject is currently involved in a study of another investigational product for similar purpose.
• Currently seeking or receiving workman’s compensation.
• In active spinal litigation
  

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.