title: Survivorship of coflex Interlaminar-Interspinous Implant.
abstract: BACKGROUND
  The purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients.
  
  
  METHODS
  A total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.
  
  
  RESULTS
  The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no devicerelated issues and 8% had device-related issues.
  
  
  CONCLUSIONS
  The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.
  
  
  CONCLUSIONS
  Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.
authors: NYU-Hospital for Joint Diseases, New York, New York USA.
authors: Thomas J
authors: TJ
authors: Errico
authors: NYU-Hospital for Joint Diseases, New York, New York USA.
authors: Jonathan R
authors: JR
authors: Kamerlink
authors: NYU-Hospital for Joint Diseases, New York, New York USA.
authors: Martin
authors: M
authors: Quirno
authors: Chirurgie Orthopedique, Lyon, France.
authors: Jacques
authors: J
authors: Samani
authors: Paradigm Spine, LLC, New York, New York USA.
authors: Robert J
authors: RJ
authors: Chomiak
keywords: Interspinous “U”; coflex; interlaminar-interspinous implant; long-term outcomes; spinal stenosis; spine arthroplasty