Failed Spinal Fusion Syndrome

A bone growth stimulator is a useful adjunct therapy if you are at risk for failed fusion after spinal fusion surgery. It is estimated that failed spinal fusion syndrome affects between 10 to 40% of patients after surgery. There are many factors such as health conditions and surgical complications that may contribute to the failure of spinal fusion, also known as pseudarthrosis.

In this blog article we will review when a bone growth stimulator may be prescribed to assist with bone growth after spinal fusion surgery.

What Is Failed Spinal Fusion Syndrome?

Failed spinal fusion syndrome is the result of a failed spinal surgery. Patients experience intractable pain and often are unable to cope with daily routines. In most cases the surgery was ineffective rather than incorrectly performed.

Non-invasive options are available to treat back pain before spinal fusion surgery is attempted. These include:

• Reduced physical activity
• Nonsteroidal anti-inflammatory medications (NSAIDs)
• Corticosteroid injections
• Physical therapy

Spinal fusion surgery is invasive and performed under general anesthesia. The surgery will be performed either from the posterior (back) or anterior (front) depending on where the discs being operated on are located. Lumbar discs are normally accessed from the back and cervical discs are accessed from the front. A PubMed article from 2015 found that spinal fusion surgeries performed posteriorly resulted in fewer complications during a 2 year period after surgery.

The damaged discs are immobilized and mechanically joined together to create stability during a spinal fusion surgery. Bone graft material is added between and around the discs to promote the growth of new bone growth (osteogenesis) which will become a permanent disc structure over time. It is important to immobilize the back for new bone growth post-surgery. This can be accomplished with a back brace that will limit range of motion and support the spine.

When constant back pain is present after the surgery and does not diminish over time, it is considered to have failed. Other symptoms such as radiculopathy, stenosis, or increased instability are also indications of a failed fusion surgery.

Bone Growth Stimulator Adjunct Treatment

After spinal (cervical or lumbar) fusion surgery a bone growth stimulator may be recommended by your doctor as an adjunct therapy. This means a bone growth stimulator is an additional treatment added to your primary care program. Your surgeon may determine an invasive (implantable) stimulator should be implanted during surgery. Another option is a non-invasive stimulator that is worn over the surgical site. Both options provide pain-free treatments and are used to promote bone growth at the spinal fusion site. Our blog article about bone growth stimulators explains how the devices work to promote osteogenesis.

A bone growth stimulator can also be prescribed when failed spinal fusion syndrome is identified. This non-invasive therapy option is performed prior to additional invasive surgery.

Medical Necessity

Let your doctor know about any health condition which could affect how your bones heal when consulting with your doctor about a spinal fusion surgery. There are pre-existing genetic conditions, as well as lifestyle choices, that can negatively impact how long your bones take to heal or the likelihood of successful new bone formation. 

The following medical conditions are generally considered to be medically necessary reasons for a bone growth stimulator prescription:

• Previous non-union bone fracture
• Failed fusion of a joint 
• Congenital pseudarthrosis
• Alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco use, steroid use

Indications for Use

The FDA defines the Indications for Use of a medical device in 21 CFR 814.20(b)(3)(i) as: "A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended." The general indication for use of a bone growth stimulator is to promote bone growth which is critical for a successful spinal fusion.

Indications for use that have been approved by the FDA include:

• Spinal fusion adjunct to increase the probability of fusion success 
• Non-operative treatment of salvage of failed spinal fusion
• Treatment of failed fusions of the appendicular system
• Adjunct to lumbar or cervical spinal fusion

Treatment Use

Your doctor will provide instructions on the frequency of use and duration. Some bone growth stimulator treatments are performed multiple times daily while others are pre-set for a single 30 minute therapy session.

The therapy session duration is dependent upon the device manufacturer's recommended pre-set time or a maximum total therapy duration. A 30 minute therapy is representative of a pre-set therapy duration.

We're Here to Help

The team of experts at Elite Medical Supply is here to help identify the right non-invasive bone growth stimulator for your condition and back braces for your recovery. We offer a wide selection of devices from world-class manufacturers to help alleviate the pain and heal your spinal fusion. Take a look at our selection of bone growth stimulators by clicking here.

When you're ready to order a brace or need assistance making a choice we're here to help. You can reach us at 866-712-0881, send us an email, or fill out a contact form.