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

Inclusion criteria

• 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;
• 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

• Prior fusion or decompressive laminectomy at any index 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;
• Grade II or greater spondylolisthesis;
• Isthmic spondylolisthesis or spondylolysis (pars fracture);
• Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
• Osteoporosis;
• 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;
• Active or chronic infection - systemic or local;
• Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
• Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
• Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
• Patient is unwilling to complete his/her surveys.