What are the expected outcomes and benefits of surgery with the activL® Artificial Disc?
These facts are given to help you make the right choice about artificial disc surgery.
There are good reasons to choose an artificial disc. The activL Artificial Disc may help end or lessen your pain and discomfort.
Surgery with the activL Artificial Disc:
- Will remove your worn out disc
- May help maintain motion in your low back
- May match the disc height to the levels above and below which may help un-trap nerves
- May lessen your back and/or leg pain
- May lessen any leg tingling
- May help you return to your normal life
In the U.S. clinical trial of the activL Artificial Disc, 218 randomized patients were treated with the activL Artificial Disc and 106 randomized patients were treated in the control group with either the DePuy Spine Charite™ or the Synthes Spine Prodisc-L Artificial Disc (other FDA-approved lumbar total disc replacement devices). Some of the trial results at two years after surgery are described below. The clinical benefit beyond two years has not been measured. Ask your doctor for more details about the clinical trial and its results.
- Patients in both treatment groups experienced significant improvements in clinical outcomes at all postoperative follow up visits (including pain, function, and quality of life questionnaires).
- The improvements were similar in both treatment groups.
- In the trial, 88% of evaluated activL Artificial Disc patients (88 out of 100) demonstrated meaningful improvement in an outcome measure designed to evaluate patient function known as the Oswestry Disability Index (ODI), compared to 80% of control group patients (80 out of 100), two years after surgery.
- In addition, 93% of both activL Artificial Disc patients and control group patients (93 out of 100) in the trial had the same or improved neurological status two years after surgery.
- Two years after surgery, there were more activL Artificial Disc patients (70% or 70 out of 100) in the trial who had the same or improved motion at the surgery level than there were control group patients (52% or 52 out of 100).
- A similar number of patients in both the activL Artificial Disc group (96% or 96 out of 100) and the control group (97% or 97 out of 100) had no implant failure that required another surgery at the same level within two years after surgery.
- In addition, 86% of activL Artificial Disc patients (86 out of 100) in the trial had no serious implant related complications; compared to 79% of control group patients (79 out of 100) within two years after surgery.
- A similar number of patients in both the activL Artificial Disc group and the control group had improvement in low back and leg pain in the first two years after surgery.
Moreover, 82% of activL Artificial Disc patients (82 out of 100) were very satisfied with the results of their surgery two years after the surgery, compared to 78% of control group patients (78 out of 100).
Preparing for your activL Artificial Disc surgery
Follow your doctor’s directions when getting ready for your surgery.
Here is a list with examples of things you may be asked to do before surgery.
Your doctor’s directions may be different.
- Check whether the medicine(s) you are currently taking (including non-prescription drugs, herbal supplements, and vitamins) will still be OK to take after having back surgery.
- Take time before going to the hospital to arrange for your life after surgery
- Move anything you use a lot to an easy to reach spot.
- Remove safety hazards that may cause you to fall or lose your balance.
- Arrange to have family or friends around to help you.
- You will likely be told not to eat or drink the night before the surgery.
- Ask your doctor to tell you what to expect from this surgery.
What will happen during your activL Artificial Disc surgery?
In the operating room:
- You will lie on your back on a table and be put into a deep sleep (general anesthesia).
- Once asleep your belly area will be washed. A clean (sterile) sheet will be taped around your belly.
- A 2-3 inch (5-8 centimeter) long cut (incision) will be made on your lower belly. Your doctor will move the muscles and blood vessels to the side. This will make a tunnel to your spine.
- Your doctor will remove the damaged discs and put in the proper size activL Artificial Disc. Fluoroscopy (X-rays) may be taken during surgery to check the placement of the activL Artificial Disc.
- The cut muscle and skin will be sewn together with surgical thread (sutures). A bandage or biologic glue will be placed across the cut.
- While asleep, you will be moved to a new area (recovery room). Nurses will check your blood pressure, heart rate, and breathing. If you are in pain, you may be given medicine.
- Once awake, you may be moved to a different room.
What will happen after your activL Artificial Disc surgery?
Ask your doctor to describe how you will feel and what you will need to do after surgery. Replacing your disc with the activL Artificial Disc is a major surgery. Getting better will take time. How fast you get better will depend on your age, your general health, and the reason for your surgery. Your doctor may recommend exercise with the help of a physical therapist. As with any surgery, it is very important to follow your doctor’s directions after surgery.
Here are some examples of directions you may be asked to follow after your surgery. Your doctor’s directions may be different:
- You will likely stay one to three nights in the hospital.
- You will likely be asked to sit, stand, and walk within 24 hours after the surgery.
- You may be asked to wear a back brace to help lessen back movement for about a week after surgery.
- You may be given medicine (by mouth) for pain or sickness of the stomach (nausea).
- You will be given a new, clean bandage for your incision as needed. The doctor or nurse may show you how to change the bandage.
- You will be asked to set up a time to visit your doctor to check your healing. Your doctor may take X-rays to look at the activL Artificial Disc placement in your back.
- After your surgery, do not do any heavy lifting, excessive bending of your back, or any long or difficult activity. You may need to limit your activity for weeks to months depending on your level of healing. Your doctor will give you more specific directions on when it is OK to return to your normal bending and turning.
- After your surgery, talk to your doctor about the proper way to recover including a physical therapy plan.
It is very important to closely follow your doctor’s specific instructions so that you recover as quickly as possible and have the best possible outcome.