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

Completed

Conditions studied: Spinal Stenosis

In brief

The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.

Key facts

Study ID

NCT02457468

Run by

Predicted, Reported and Observed Outcomes Foundation

People needed

325

Starts

2015-06-01

Expected to finish

2019-12-01

Last updated by the study team

2019-12-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Neurology and Spine — Phoenix, Arizona, United States
• Arizona Brain and Spine — Scottsdale, Arizona, United States
• Northwest NeuroSpecialists — Tucson, Arizona, United States
• The Spine Institute, Center for Spine Restoration — Santa Monica, California, United States
• Cantor Spine institute — Fort Lauderdale, Florida, United States
• Southeastern Integrated Medical — Gainesville, Florida, United States
• The Orthopaedic Institute — Gainesville, Florida, United States
• The BACK Center — Melbourne, Florida, United States
• All Florida Orthopaedics — St. Petersburg, Florida, United States
• Laser Spine Institute — Tampa, Florida, United States
• OrthoAtlanta — Lawrenceville, Georgia, United States
• Orthospine Center LTD — Palos Heights, Illinois, United States
• Orthopedic Center of Illinois — Springfield, Illinois, United States
• Brigham and Women's — Boston, Massachusetts, United States
• New England Orthopedic Surgeons — Springfield, Massachusetts, United States
• The Orthopedic Center of St. Louis — St Louis, Missouri, United States
• Orthopedic Sports Medicine & Spine Care Institute — St Louis, Missouri, United States
• North Jersey Brain and Spine Center — Oradell, New Jersey, United States
• IGEA Brain and Spine — Union, New Jersey, United States
• Spine and Orhtopedic Center of New Mexico — Roswell, New Mexico, United States
• Bassett Medical Center — Cooperstown, New York, United States
• Blue Ridge Bone and Joint — Arden, North Carolina, United States
• OrthoNeuro — Dublin, Ohio, United States
• Consulting Orthopaedic Associates — Sylvania, Ohio, United States
• OrthoTexas — Carrollton, Texas, United States

Full record on ClinicalTrials.gov

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