The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation.
The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products.
"Bone grafting is an essential part of spinal surgery and ever-evolving science," concluded the recommendation authors. "With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision."
The recommendation authors found:
• Nonstructural cancellous allograft a viable option
• Published studies support the use of DBMs and synthetic bone substitutes as autograft extenders
• While cellular allograft materials (CBMs) are marketed under the FDA's HCT/P guidance, there isn't evidence to support broad use
• There is evidence to support appropriate aspirated bone marrow aspirate use as an adjunct to bone grafting during fusion
• Two pre-market approval products in the drug-device category that show promise as safe and effective allograft replacements are Medtronic's InFuse and Cerapedics' i-FACTOR
"The value of the bone graft substitutes recommendations and coverage criteria is to give surgeons the tools they need to make an educated decision regarding bone graft substitute choice in a value based setting and to know the particular clinical pathway required for same to gain approval," said Dr. Lorio. "Just because a material has an FDA guidance label doesn't mean that it works and has solid data behind it."
The statement also reiterates the importance of collecting supportive data by industry. Looking ahead at innovations in stem cell products, Dr. Lorio sees a narrow time window for manufacturers engage with the FDA in a collaborative guidance process during this discretionary period so that regulatory requirements are not side-stepped.
"Those companies that self-launch must self-invest with quality research and collaborative engagement with the FDA to strengthen that relationship. Unless there is solid data to support product claims, many biologic CBMs will simply go away," said Lorio.
ISASS also issued a policy statement on vertebral augmentation to outline the procedure's background after collecting clinical evidence to support the procedure. "Given the abundance of high-quality information, ISASS can confidently advocate that there is strong support for vertebral augmentation in the treatment of symptomatic vertebral compression fractures," according to the statement.
The 2010 AAOS Guidelines and a recent Journal of Bone and Mineral Research (JBMR) report by non-experts question the efficacy of vertebral augmentation. A very recent paper published within Osteoporosis International demonstrates real world insight into the higher risk of mortality imposed on patients with vertebral compression fractures treated with a philosophy of 'intelligent neglect.' "Untreated compression fractures lower one's lifespan by approximately four years as demonstrated by Edidin et al; non-surgical management (NSM) rations lives," said Dr. Lorio.
The statement also addresses the cost-effectiveness of vertebral augmentation, citing studies that show non-surgical, conservative management of female patients with VCF continues to cost the healthcare system five years after the fracture occurs. On the other hand, balloon kyphoplasty and vertebroplasty are proven cost-effective in terms of cost per quality year gained when compared with non-surgical management.
"Although the initial cost of the intervention is higher, balloon kyphoplasty is more cost effective than vertebroplasty by providing better pain control and decreasing costs related to oral narcotics in addition to providing survival benefit," according to the statement.
In addition to providing background information and study review analysis, the statement makes clinical indication for coverage recommendations as well as provides a discussion of coding and documentation requirements.
"Vertebral augmentation procedures (vertebroplasty and kyphoplasty) are safe and effective procedures that have been highly studied," the statement authors conclude. "The level 1 evidence is overwhelming in favor of vertebral augmentation when compared to conservative management."