|
Artificial disc replacements (ADRs) are still under investigational study. This means the FDA has approved their use but controlled, clinical studies are ongoing. As many as 14 investigational sites across the United States are involved in the FDA Investigational Device Exemption (IDE) studies.
Patients are selected carefully to ensure success. Only a small percentage of patients are actually eligible for an ADR at this time. Patients must be skeletally mature without evidence of osteoporosis (brittle bones). This usually restricts their use to patients between the ages of 18 and 60. Patients with severe degenerative disc disease are usually excluded at this time.
Older adults with serious health conditions who might be at risk of adverse events (including death) are not included. But whether or not age by itself should be a limiting factor was recently studied. Researchers from the Texas Back Institute compared adults 45 years and older to adults younger than 45. Each patient received a single-level ADR in the lumbar spine.
The results were measured based on levels of pain and function, range of motion, and patient satisfaction. Age was not a key factor in the results. Total disc replacement relieved pain and decreased disability in both age groups. Patients recovered at about the same pace no matter what age they were.
Patients will still be screened carefully but in the future, the acceptable age for ADRs may be extended for older adults. In other words, age may not keep older adults from benefitting by this treatment approach to relieve pain and preserve motion. Anyone with early signs of osteoporosis (called osteopenia) or known osteoporosis may not qualify at any age.
|
