Optimizing Clinical Use of Biologics in Orthopedic Surgery - Project Summary/Abstract
There is substantial interest in using biologics to reduce body and joint pain and to accelerate healing from
orthopaedic injuries and surgery1,2. Musculoskeletal problems attributed to injuries and aging are the leading
cause of disability in the United States3. In recent years, there has been an exponential rise in the use of
biologics to treat orthopaedic problems. This rise is primarily due to widespread use of “minimally manipulated”
autologous therapies such as platelet rich plasma (PRP), that are not required to undergo pre-market
approval/clearance from the Food and Drug Administration1. Consequently, clinical use of these treatments
has greatly outpaced evidence based research. Concerns over misinformation and patient safety have led to
recent calls to action, including one from the American Association for the Advancement of Science5. The
orthopaedic professional societies and research communities share these concerns. To address these
concerns, Optimizing Clinical Use of Biologics in Orthopaedic Surgery Research Symposium will be a
collaborative and interactive meeting to develop a collective impact agenda to promote informed regulation and
funding of new pathways for the clinical evaluation of biologics. Specifically, the symposium aims to determine
candidate biologic targets for common orthopaedic conditions and injuries, identify a process to determine
what is known about the composition and biologic activity of biologics using PRP as a model, determine the
feasibility of establishing a clinical registry to collect data on the use of biologics, and identify regulatory
pathways to facilitate their use. Symposium faculty and participants will consider clinical trial designs to include
use of adaptive clinical trials to test the efficacy of PRP. A combination of didactic talks presented by subject
matter experts followed by small group discussions modeled after the NIH/NIAMS Roundtable format will be
used to achieve the aims. Symposium participants will be comprised of orthopaedic physicians, the scientific
community including NIH and FDA, and young investigators whose research focuses on biologics. The general
sessions of the symposium will be open to registrants. The resultant consensus documents, including draft
guidance on clinical assessment of biologics that can impact regulatory pathways, are of critical importance to
implementing a framework for responsible and evidence based translation of new biologic treatments into
clinical use to treat orthopaedic problems. These outcomes serve the public interest and have high potential to
positively impact patient care and public health.
