Last updated on December 2019

The Coflex COMMUNITY Study: An Observational Study of Coflex Interlaminar Technology

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Spinal Stenosis
  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
  2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.

Exclusion Criteria:

  1. Prior fusion or decompressive laminectomy at any index lumbar level;
  2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
  3. Severe facet hypertrophy that requires extensive bone removal which would cause instability;
  4. Grade II or greater spondylolisthesis;
  5. Isthmic spondylolisthesis or spondylolysis (pars fracture);
  6. Degenerative lumbar scoliosis (Cobb angle of greater than 25);
  7. Osteoporosis;
  8. Back or leg pain of unknown etiology;
  9. Axial back pain only, with no leg, buttock, or groin pain;
  10. Morbid obesity defined as a body mass index > 40;
  11. Active or chronic infection - systemic or local;
  12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
  13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
  14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
  15. Patient is unwilling to complete his/her surveys.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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