Evaluation of Novel Cartilage Treatment Options for Clinical Use

Every year there are new cartilage treatments available for clinical use. It is often challenging for the surgeon to choose among a growing menu of treatment options. To ensure appropriate product selection, the surgeon must have a firm understanding of the evolving Food and Drug Administration regulatory pathways, insurance medical policies, and must also be well versed on basic science and clinical evidence in support of the product. Depending on the required Food and Drug Administration pathway, available products range from loosely regulated (animal studies and limited clinical data) to tightly controlled (phased randomized control studies). Challenges and limitations are incumbent with products brought to market through either pathway. Therefore, it is important to develop a personal system to evaluate each novel product-as new is not always better. In this article, we provide the framework for evaluation and integration of novel products into cartilage practice. Through case examples, we highlight pearls and pitfalls in the adoption of new technology from a variety of regulatory pathways. Finally, we provide an overview of existing cartilage treatment options and novel products in the approval “pipeline.”