Beware of Non-Evidence-Based Therapies

Nearly 27 million Americans suffer from osteoarthritis, the most common chronic, degenerative condition that affects the joints. Healthy joints have multiple layers of cartilage that provide cushioning and help joints move smoothly. As osteoarthritis progresses, it involves ongoing cartilage degeneration that results in swelling, pain, and a reduced range of motion.

Osteoarthritis symptoms can become quite severe and debilitating, and sufferers commonly seek treatment options that are less invasive and do not involve surgery. For these patients, a new wave of treatment marketed by some providers as “regenerative” or “bio-restorative” medicine may sound like a hopeful alternative to more traditional management of osteoarthritis symptoms or even joint replacement surgery. But Orthopedic Surgeon, J. Craig Morrison,MD, with Southern Joint Replacement Institute cautions, “Buyer beware!”

“Recent publicity about professional athletes treated with biologic injections to stimulate the healing of sports and joint injuries has helped fuel a new market for intra-articular injections, including autologous stem cell injections and plateletrich plasma injections, also known as PRP, for the treatment of osteoarthritis,” said Dr. Morrison. “But it is important for patients to understand that these type treatments are controversial in the medical community and considered experimental or investigational by most insurance companies. There is currently no science to support the idea these injections can cure or reverse osteoarthritis.”

According to Dr. Morrison, limited studies have shown some patients experience relief from pain and increased function for a while after receiving PRP injections, but these studies have not followed patients for a long period of time and the patient samples were very small.

“It is very important for patients to consider their options through a risk-benefit analysis, particularly those who have reached a stage of degeneration that requires joint replacement.” said Dr. Morrison. “First and foremost, there is no evidence these biologic injections can regrow the joint cartilage. Secondly, the cost of a series of injections of autologous stem mesenchymal stem cells (MSCs) or platelet-rich plasma (PRP) can range from $1,500-$10,000, and is typically not covered by insurance. If you happen to be one of the patients who responds to this type of therapy, you may feel better for a year without changing the underlying degenerative process. This leaves you with a knee that may still require knee replacement, but a lot less money in your pocket.

Dr. Morrison outlined a number of other considerations for patients contemplating this alternative treatment path:

  • These injections are not the same as corticosteroids or hyaluronic acid injections commonly used to treat symptoms of inflammation and pain associated with osteoarthritis.
  • The procedures are not painless. Bone marrow extraction for producing the autologous stem cells can be very painful.
  • There are very few studies supporting the efficacy of these types of intra-articular injections for the treatment of osteoarthritis. The studies that do exist contained very small patient samples sizes, examined differing delivery methods and often had ill-defined outcome measures. (Source: American Journal of Orthopedics)
  • With few exceptions, studies show that patients who benefit from biologic injections are younger, and in the earliest stages of osteoarthritis-related joint degeneration.
  • Existing studies have followed patients for only a short period of time, in many cases as little as 12 months.
  • Administration of concentrated mesenchymal stem cells (MSC) and platelet-rich plasma (PRP) into joints is not currently FDA approved and there is currently no quality oversight or standardization for clinics and providers administering these injections.
  • Stem cell procedures in orthopedics are still at an experimental stage and most musculoskeletal treatments using stem cells are performed in research centers as part of controlled clinical trials. (Source: American Academy of Orthopedic Surgeons (AAOS))

Conversely, patients who receive a joint replacement for end stage arthritis have an excellent chance of enjoying life with a pain-free joint for 20 years or more, according to Dr. Morrison.

Joint replacement has advanced tremendously in the past 10-15 years,” he said. “Advanced materials and enhanced surgical techniques help replacement joints last longer and function more closely to a normal joint. Further, more sophisticated anesthesia and pain management techniques, combined with patient specific physical therapy protocols result in less post-surgery pain and a quicker return to functional recovery.”

Typically, joint replacement is a last option when other methods of symptom management have lost effectiveness or the patient decides their quality of life has been too adversely affected.

Dr. Morrison admits it is not difficult to understand why patients are looking alternatives, but encourages patients to carefully educate themselves about their medical choices and to talk frankly with their family physician or orthopedic surgeon about all of their options for effectively managing osteoarthritis.

“If you are considering these injections, make sure you understand exactly what is being injected and what outcomes should be expected,” he said. “And if you are going down this road, I strongly encourage you to do so at a research center that is engaged in robust evidence-based studies.”

tags: orthopaedics

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