Locations:
Search IconSearch

Orthobiologics and Orthobiologic Research: The Current State

Understanding applications, tracking outcomes and creating standards for use

17-OR-1164-King-Hero-Image-650x450pxl

By Dominic King, DO; Jason Genin, DO; George F. Muschler, MD; and Nicolas Piuzzi, MD

Advertisement

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

For the uninitiated, the term orthobiologics refers to all treatments that utilize molecules, cells or tissues to aid in the healing and reparative process of a musculoskeletal injury or chronic orthopaedic condition. This includes cell-based therapies and platelet rich plasma (PRP), about which orthopaedists are hearing increasingly more from colleagues and answering many questions from patients.

Addressing a lack of understanding and standardization

Several studies on the use of cell-based therapies and PRPs have demonstrated marked heterogeneity between preparations, appropriate uses and patient-reported outcomes. This lack of standardization undermines the ability to reliably reproduce studies. Consequently, there is a glaring lack of large-scale, high-quality research.

Recognizing the powerful potential applications of these treatments, Cleveland Clinic has undertaken a proactive approach to developing solid standards that we hope will guide our and other teams’ use of these new therapies. This effort is an important component of the newly established Cleveland Clinic Joint Preservation Center.

Tracking protocols, safety, efficacy, outcomes

Our approach to developing these standards started with the creation of a reliable tracking mechanism. We developed a specific orthobiologic module within Cleveland Clinic’s OrthoMiDaS Episode of Care system, in collaboration with Kurt Spindler, MD. The module ensures standardization of injection protocols and tracks longitudinal safety, efficacy and outcomes for every orthobiologic treatment performed at our institution.

Each of these treatments is just beginning to be understood in detail, and clinical efficacy is still to be proven. Therefore, insurance coverage is minimal and patients must usually pay out of pocket. We offer these treatments as part of a comprehensive, multimodal program combined with physical therapy, bracing and activity modification in a safe, controlled environment.

Advertisement

Building on previous research here

We have also collaborated with George F. Muschler, MD, who has been a referral source in orthopaedic regenerative medicine research. He and his team have optimized surgical techniques for bone marrow aspiration to improve the yield of stem and progenitor cells (connective tissue progenitors or CTPs), designed standards to measure cell-based therapies, and improved understanding of the complexity of multiple orthobiologic treatments.

Problems in tendinopathy classification

The lack of consistency in orthobiologic use, specifically in the treatment of tendinopathies, is fundamentally related to the lack of a reliable tendon damage classification system. Ultrasound findings, such as tendon thickening, hypoechogenic tendinosis, neovascularization denoted by power Doppler-flow-enhanced hyperemia and intrasubstance partial tearing, all may result in different outcomes after the same orthobiologic injection. Yet these are lumped into a single general category of “tendinopathy” in most research articles. Recognizing the lack of a standard classification system, we are also developing our own tendinopathy classification system at Cleveland Clinic.

Where to go from here

There has been a paucity of high-quality, reproducible research for orthobiologics. Instead, we have mostly relied on trial-and-error approaches. To rectify this situation, we are laying the foundation to build standards that will help ensure excellent outcomes for patients.

This includes a transparent, controlled, evidence-based effort to understand pathologies underlying the maladies we treat and the mechanisms of action of orthobiologic products and, most importantly, to set reproducible standards in orthobiologic care. Data we collect will help guide our research directives and establish national guidelines for orthobiologic research.

Advertisement

We look forward to sharing our evidence and having ongoing discussions with colleagues about our approach and findings, and we welcome your feedback.

Dr. King and Dr. Genin are staff physicians in Sports Medicine and Medical Orthopaedics in the Sports Health Center and Joint Preservation Center. Dr. Muschler is a Professor of Orthopaedic Surgery, specializing in all aspects of knee and hip replacements. He is Director of the Regenerative Medicine Laboratory, where he conducts research on bone and cartilage tissue regeneration. Dr. Piuzzi is a clinical scholar in Orthopaedic Regenerative Medicine and Cellular Therapies.

Advertisement

Related Articles

Hospital Doctor  Talks To Male Patient
December 17, 2021/Orthopaedics/News & Insight
Orthopaedics Makes Widespread Changes to Advance Care Quality and Patient Safety

Cross-team efforts improve plan-of-care visits, update readmission strategies and increase compliance with Universal Protocol

19-ORT-1067-Leg-Repair-Hero
Reconstructing Nonunions of the Distal Tibia

Approaching distal tibial nonunions

16-ORT-1508-Tejpar-Hero-Image-650x450pxl
Orthobiologics Update: The Search for Reproducible Evidence Continues

Progress has been made, but there is still no categorical evidence of efficacy

18-ORT-1197-Higuera-Hero-Image-650x450pxl
September 4, 2018/Orthopaedics/News & Insight
A Potential Treatment for Periprosthetic Joint Infection after Total Joint Arthroplasty

Novel approach combines magnetic hyperthermia, amino acid gel to disrupt bacterial biofilm

17-ORT-1165-Mont-Hero-Image-650x450pxl
Cleveland Clinic Joint Preservation Center Now Up and Running

Organizing and overseeing joint preservation efforts

17-ORT-1161-Saluan-650×450
Elevating Arthroscopy Skills

High-tech educational program scores well

Ad