Artificial disc replacement candidates

The overall indications for a CHARITÉ Artificial Disc are similar to that for an anterior lumbar interbody fusion (ALIF) using BAK interbody cages. Currently, the CHARITÉ Artificial Disc is only available for use for one-level disc replacement, so it is not indicated for patients with symptomatic multi-level disc disease.

In summary, lumbar disc replacement surgery is in its infancy and is presently indicated for single-level, painful degenerative disc disease that has failed to improve after at least six months of intensive spine-focused rehabilitation in a patient without major psychological, physical or social/emotional contraindications.

Potential candidates for the CHARITÉ disc replacement surgery may include:

• Diagnosis of degenerative disc disease or post-laminectomy syndrome at either L4-L5 or L5-S1 levels of the lumbar spine

• Patients who are between the ages of 18 and 60

• Patients who suffer from low back pain as the major complaint (rather than leg pain)

• Patients who have not responded to a minimum of six months of conservative treatments (non-surgical care, such as physical therapy, pain medications, etc.)

• Patients who are a candidate for spine surgery (such as a lumbar fusion)

• Patients who have only one level disc disease (either bottom disc level, L5-S1, or the second to the bottom, L4-L5)

Patients who are not candidates for the CHARITÉ disc replacement include those who have:

• Infection

• Spinal stenosis

• Spondylolisthesis (or other types of instability in the spine, such as fracture or tumor). Patients who have only minor slippage of the vertebrae (0.3mm or less) may still be candidates.

• Scoliosis

• Posterior facet joint disease (i.e. facet joint osteoarthritis)

• Significant radiculopathy (pain radiating down the leg)

• Osteoporosis or poor bone quality (osteopenia)

• Pregnancy

Other factors in selecting candidates for the CHARITÉ disc implant may also apply in certain circumstances. For instance, the surgeon may recommend against the procedure if the patient is morbidly obese, has specific allergies, or has another medical condition. Certain psychological and emotional factors and other circumstances may also at times play a factor in deciding who may potentially benefit from the disc replacement surgery. Therefore, it is best for the patient to fully discuss his or her medical history and medical options thoroughly with the treating spine surgeon before deciding about the surgery.

As with all surgical procedures, it is critical that the indications for the CHARITÉ Artificial Disc are respected in order for the surgery to potentially be safe, successful and meet the FDA agreed upon protocol. In addition to the FDA-recommended patient selection criteria, the FDA has also recommended that several conditions be followed, including:

• Development of ways to track patients (such as issuing patient implant cards) in case of a future recall or the disc or other problem

• Making sure that appropriate surgeon training is provided

• Conducting further biomechanical studies

• Continuing with additional follow up of clinical study patients.