Who should be treated with the activL® Artificial Disc?
The activL Artificial Disc may be considered in patients who:
Are skeletally mature (have vertebrae that are fully formed and grown).
Have low back pain with or without leg pain due to a problem with one (1) degenerated lumbar disc at either level L4/L5 or level L5/S1 (as determined by a doctor).
May have neurological symptoms such as weakness or numbness if the damaged disc is irritating the nerve roots (radiculopathy).
Have proven disc degeneration at only one lumbar disc level (L4/L5 or L5/S1) and have been diagnosed as having Degenerative Disc Disease (DDD) at that level as confirmed by a doctor’s review of their medical history, physical examination and medical images.
Have gone through at least six months of non-surgical treatment without relief.
Your medical history is very important in your doctor’s decision to choose the activL Artificial Disc for you.
Before recommending the activL Artificial Disc, your doctor will take into account your past and present health such as:
- Your job and activity level
- Your current and past mental and physical health
- Alcoholism or drug abuse
- Medicine use
- Previous treatments
You may be asked questions to help decide if you have a risk of low bone mineral density. Based on your answers, your doctor may order a bone test (DEXA measurement). The activL Artificial Disc has not been tested in patients with a spinal DEXA T score less than or equal to -1.0 (who may have osteoporosis or osteopenia).
Your doctor will choose the best activL Artificial Disc size for your body.
A correctly sized activL Artificial Disc is important so that the implant stays in place and works right for you. Your doctor should not start surgery without the right implant size or instruments that are in good working order.
This implant is placed close to major blood vessels and nerves. There is a risk of nerve damage and/or serious or fatal bleeding if these structures are damaged during surgery.
Your doctor should talk to you about all of the risks and complications associated with the activL Artificial Disc and give you plenty of time to ask questions. You can also ask to see the full list of precautions and risks and complications which are listed in the activL Artificial Disc package insert.
It is extremely important that you let your doctor know about any medications you are taking, any allergies you have, if you are pregnant, may become pregnant, or if you have any other illnesses or medical conditions that may help your doctor decide if this implant is right for you. Failure to fully inform your doctor about your overall state of health and existing medical conditions may create unnecessary complications if you are treated with this implant.
It is also very important that you carefully follow your doctor’s instructions after surgery. Extreme activities like lifting very heavy weights may result in failure of the implant.
Will your doctor recommend the activL Artificial Disc surgery for you?
First your doctor will prescribe non-surgical treatments, such as medications, physical therapy and/ or injections.
If these treatments do not relieve your pain, your doctor may determine that you are a candidate for artificial disc replacement.
Talk to your doctor about your options including the risks and benefits of surgery using the activL Artificial Disc to treat your condition. Surgery with the activL Artificial Disc may be an option to help your pain and other problems related to a damaged lumbar disc.
Who should not be treated with the activL Artificial Disc (Contraindications)?
If you have any of the following conditions, you should not have surgery with the activL Artificial Disc:
- Active whole body (systemic) infection such as pneumonia or infection near the surgical site because undergoing surgery could interfere with your ability to heal and could increase the chance of spreading or worsening the infection.
- Osteoporosis or osteopenia (thin or weak bones). These conditions could increase the risk of your bones breaking or could cause the implant to loosen.
- Allergy or sensitivity to the materials that make up the activL Artificial Disc (cobalt, chromium, polyethylene, titanium, tantalum, or calcium phosphate). Talk to your doctor if you have a metal allergy because use of the activL Artificial Disc could cause an allergic reaction.
- Leg pain caused by single nerve root compression (“pinched nerve”) because your pain may be treated with a different surgical procedure.
- Narrowing of the spinal canal (stenosis), nerve root damage (chronic radiculopathy), disc fragment that has separated and moved from the disc space, or spinal deformity such as scoliosis because surgery with the activL Artificial Disc may not be able to treat your symptoms.
- Too much forward slippage of your upper vertebra with respect to your lower vertebra (spondylolisthesis > grade 1) or a fracture (break) in a specific location in your vertebrae (referred to as a pars defect) as determined by your doctor which could cause instability within your spine.
- A lumbar spine that shows an unhealthy amount of extra movement (instability) on x-rays because the activL Artificial Disc may not provide enough stability.
- Damaged lumbar vertebrae due to an accident (trauma) or disease (including inflammatory diseases where the vertebrae swell or grow together and limit movement such as ankylosing spondylitis and rheumatoid arthritis). Use of the activL Artificial Disc in these situations may lead to poor performance of the implant.
- Severe disease or degeneration in the joints in the back of spine (facet joints) as determined by your doctor because surgery with the activL Artificial Disc will not treat this.
- Too little space remaining between the vertebrae because the disc has collapsed too much. In these cases, the activL Artificial Disc will not be able to function properly.
- Disc degeneration requiring treatment at more than one level as the activL Artificial Disc has only been evaluated in patients with one lumbar disc requiring treatment.
- Existing conditions that would make surgery through the belly impossible.