Coflex ® back surgery is a non-fusion spinal treatment.
What is a Coflex ® Spinal Implant?
The coflex ® device is implanted in a type of back surgery. It is used in an Interlaminar Stabilization procedure, and it “is a titanium metal implant that helps keep your spine stable after surgical decompression”. Coflex ® is utilized in patients with spinal stenosis.1 Spinal stenosis is “a narrowing of the bone channel occupied by the spinal nerves or the spinal cord”. This causes nerve compression and pain in the regions of the lower back (lumbar) and neck (cervical). Rarely, stenosis occurs in the middle/upper back (thoracic).2 Spinal stenosis symptoms include numbness, pain, and weakness in the lower extremities. Typically, surgical options for spinal stenosis were limited to spinal fusion. The problem with that type of surgery is that it “eliminates motion in the spine”. The coflex ® Interlaminar Stabilization method of surgery is a non-fusion option in which a titanium implant keeps the “spine stable after surgical decompression” and “helps maintain the normal foraminal height and motion”. The device is strong and flexible. It is said to provide faster and longer lasting relief of symptoms, greater patient satisfaction, shorter operating times and hospital stays, less blood loss, stability in the area treated, and “more natural movement”. These outcomes were part of an FDA clinical study comparing coflex ® to “pedicle screw fusion surgery for…spinal stenosis”.3
How Coflex ® Works
When a patient has decompression surgery, the spine may become unstable, and the coflex ® device increases stability by upholding the “normal foraminal height” while maintaining mobility. It is designed to be put on the “laminar bone, which is the strongest part of the spine in your lower back”. The device is implanted in the same incision as the decompression surgery so that the muscle and tissue injury is minimized.4 There are many features of the device. It is a U-shaped piece, made from titanium alloy, and it is positioned in a horizontal manner, with ridged surfaces that face the bone to “provide resistance to migration”. The alloy is visible in x-rays, and the wings are crimped for stability. It allows flexion because it is “compressible in extension”, and the device provides “increased rotational stability”. It comes in five sizes.5 An FDA clinical trial provides data about the advantages of the coflex ® implant.6 During surgical decompression, the surgeon removes soft tissue and bone, and spinal fusion is meant to stop the motion in the spine, with metal screws and rods, to provide stability. The coflex ® device is an alternative to the fusion so that the natural movement is retained in the affected area of the spine.7 The coflex ® implant is contraindicated in patients who have “osteoporosis, a narrow interspinous space and intervertebral coronal spondylolysis, or sagittal instability”. In addition, it is important that the right device is chosen, that it is implanted at the proper depth, and that the “clamping intensity” is appropriate.8
Potential complications include spinal process fracture, fixed-wing breakage, loosening of the device, superficial wound infection, and dura mater tear. In general the device “shows a low complication and re-operation rate”.9 When any surgery is done, however, there are risks, especially if surgery is performed near the spinal cord. Some patients may need additional surgery, or there could be post-operative impairment or pain. One of the problems of surgery is anesthesia, which can be local or general. Local anesthesia is injected just in the area that will have surgery, while general anesthesia “is where you go completely to sleep”. Some patients have problems with general anesthesia, and most spinal surgeries require this type of medication. Another potential surgical complication is Deep Venous Thrombosis (DVT), which means that blood clots form in the leg veins. This situation is created by the body trying to stop the bleeding caused by surgery, making the clotting mechanism hyperactive. Surgery also injures blood vessels, leading to more clotting. Stagnant blood in the veins can also contribute to clotting, and if it does not dissolve, the swelling may be uncomfortable. More seriously, the clot can break free, cutting off the blood supply to a portion of the lungs (pulmonary embolism), which could lead the death. To prevent DVT, it is important to get the patient moving so that the blood moves. The patient can increase circulation by pumping their feet, for example. They can also be provided with “pulsatile stockings”, which inflate and compress the calf periodically. Walking and wearing support hose may also help. Some patients will need medications to prevent clotting. Lungs also need exercise so that the patient does not develop pneumonia after surgery. Infection is also a risk. Depending on the type of surgery, there is also concern about hardware fracture and implant migration. Persistent pain and spinal cord injury are additional problems that could arise.10