Health Problem: Lumbar spinal stenosis (LSS), characterized by reduced spinal canal dimensions and compressed neural elements in the lower back, is predominately caused by degenerative changes in the intervertebral discs, ligaments, and bone structures of the spine. Mobility and quality of life are substantially adversely affected. LSS is the most common reason for spinal surgery in persons > 60 years of age.
Technology Description: The coflex device is a U-shaped implant manufactured from medical-grade titanium alloy designed to withstand a normal physiologic load in the spine. The device is a single-piece design with 2 pairs of serrated wings. This design allows a simple press-fit insertion of the device. Implantation is performed after decompression of stenosis at the affected level(s).
Controversy: Adverse sequelae associated with spinal fusion include symptomatic disease in adjacent spinal segments, increased morbidity, pseudarthrosis, and subsequent surgical reinterventions. As a result, less invasive motion-preserving alternatives to spinal fusion, such as the coflex device, have been developed and are under investigation.
Key Questions:
- Is use of the coflex Interlaminar Stabilization device following decompression effective in treating LSS in skeletally mature patients with or without low-grade spondylolisthesis?
- How does use of the coflex Interlaminar Stabilization device following decompression compare with standard care of decompression with fusion or decompression only?
- Is use of the coflex Interlaminar Stabilization device safe?
- Have definitive patient selection criteria been identified for use of the coflex Interlaminar Stabilization device?
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