Frequently Asked Questions
Q: Am I a candidate for the coflex® procedure?
A: To be a candidate for treatment with decompression and the coflex® device, you must be skeletally mature. You must have moderate to severe spinal stenosis in your lower back. One sign of having moderate to severe spinal stenosis is that it is hard to walk for long periods of time, such as ½ of a mile. Another sign is having pain in your lower back while standing that goes away when you bend forward. You must have been treated by a physician for at least 6 months with "non-surgical treatments" (eg, drugs [steroids], physical therapy, etc.), before receiving the coflex® device.
Q: Why may the coflex® device work?
A: The coflex® implant is designed to keep your spine stable so when you stand upright the nerves in your back will not be pinched or cause pain. In addition, the coflex® implant is intended to allow you to continue to move your back more than with a fusion surgery. With the coflex® implant in place, you should not need to bend forward to relieve your pain.
The coflex® implant was studied in a clinical trial to compare it to spinal fusion surgery. In the study of 322 patients, 215 patients received the coflex® implant as their treatment, and the rest had fusion surgery. Eighty-six (86) out of every 100 patients who had the coflex® device had a successful outcome after two years. A successful outcome meant they had relief from their pain and did not require additional surgery.
A similar outcome (77 out of 100 patients) was experienced with patients who had fusion. The coflex® device was not studied against any non-surgical method of treatment.
While pain relief happened faster (at 6 weeks) after surgery in patients who received the coflex® device (85 out of 100 patients) compared to those patients who had fusion surgery (68 out of 100 patients), if you are treated with the coflex® device, your outcome at two years is expected to be no worse than if you were treated with fusion. Benefits beyond two years after surgery have not yet been determined.
Q: What problems may happen from a coflex® device surgery?
A: There are risks with spinal implant surgery. A risk is a bad or harmful (adverse) thing together with how often it happens. In the coflex® study, surgeons anticipated that bad or harmful things might happen. If you are considering the coflex® device, your surgeon can discuss your individual risk potential.
The problems observed the most in the trial were pain, wound healing problems (such as infection or drainage), brief numbness or tingling in patient's arms or legs, and bone fracture. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion.
For some patients, the coflex® procedure may not help relieve you of your pain, and there is possibility that you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery. In the clinical study, 11 out of every 100 patients, who received the coflex® device had their implant removed, and then had other procedures to try to stop their pain.
To understand the outcomes of the clinical study, as well as the risks and benefits of the coflex® Interlaminar Stabilization™ device, please refer to the Patient Labeling. Learn More
Q: What can I expect before coflex® surgery?
A: You and your surgeon may decide that the coflex® Interlaminar Stabilization™ device is the right surgical option for you. If so, there are several things you can do that will help you have the best possible results for your surgery. Your surgeon will give you specific instructions prior to your surgery that you should follow. You can also raise your chances of a successful outcome by eating well-balanced nutritious meals before your surgery. Poor nutrition can reduce the body's ability to heal.
Q: What can I expect during coflex® surgery?
A: The procedure may be done in the operating room at the hospital or in an outpatient facility. The coflex® implant is inserted through a small cut in the skin of your back. You will be given medication so that you will be asleep during surgery. You will be unable to feel the surgery.
You will be placed on your stomach before the surgery. This will allow your surgeon to access your spine when the coflex® device is inserted during surgery. The surgery to implant the coflex® device typically lasts about one to two hours.
As part of the coflex® surgery, your surgeon will first remove part of the bone that is interfering with nerves, causing your pain. This step is called a decompression procedure. Following this step, the spinous processes are prepared to fit the coflex® device. After preparation of the bones in your spine, the coflex® device is placed between two spinous processes and is positioned securely on the laminar bone in the back of your spine. This step uses a tool that is removed after the coflex® implant is in place.
Q: What can I expect after coflex® surgery?
A: Based on the clinical study results, 85 out of 100 coflex® patients had significant pain relief at six weeks compared to those patients who had fusion surgery (68 out of 100 patients). If you are treated with the coflex® device, your outcome at two years is expected to be no worse than if you were treated with fusion. In addition, three out of four coflex® patients in the clinical study left the hospital within 24–48 hours after surgery, compared to one out of three fusion patients. In all coflex® patients in the clinical study, the hospital stay was less than a week.
Q: How soon can I resume activities of daily living after coflex® surgery?
A: Once the surgeon says you can leave the hospital, you may need physical therapy. Your surgeon may ask you to return for an examination about six weeks later. Your surgeon may also ask you to reduce your physical activities in the first six weeks after your operation.
In the clinical study, patients were allowed to travel and engage in light activity such as walking as soon as they felt they could. It is important for you to realize that you have had a surgical operation. You should not participate in some activities until your surgeon has said you may do so. Please ask your surgeon when you can start doing certain activities. Your results may be different from patients in the clinical study.
After your surgery, medication will be provided to you by your surgeon. During the clinical study, walking during the first six weeks following surgery was usually acceptable. Please listen to your surgeon’s instructions on how much activity you can do and for how long after surgery.
Q: Will my coflex® implant set off metal detectors?
A: The metal that makes up the coflex®device may affect MR Imaging and metal detectors. You can talk to your surgeon about receiving a patient ID card. This card lets people know you have a coflex® implant inside of you. You should show this card when you have X-Rays and MR Images. When you pass through an electronic detection system, you may use this card to tell security that you have this device in your spine.
If you have other questions, are looking for a surgeon near you who performs the coflex® Interlaminar Stabilization™ procedure, or would like a Patient Information Guide, click here.
This content is for educational purposes only and does not replace having a conversation with your physician. Discuss your alternatives with your physician and select the treatment method that best seems to meet your current pain level and lifestyle. Please keep in mind that treatment and outcome results vary among patients.