Background: The Minimum Information for Studies Evaluating Biologics in Orthopedics (MIBO) guidelines were developed in May 2017 to encourage improved reporting standards, promote increased transparency and reproducibility, and enhance clinical evaluation capabilities. The MIBO guidelines consist of 23 checklist items considered necessary to critically appraise clinical studies evaluating platelet-rich plasma (PRP).
Purpose: To assess randomized controlled trials that evaluated PRP for the treatment of knee osteoarthritis in order to systematically review their adherence to the MIBO guidelines.
Various types of cellular injection have become a popular and costly treatment option for patients with knee osteoarthritis despite a paucity of literature establishing relative efficacy to each other or corticosteroid injections. Here we aimed to identify the safety and efficacy of cell injections from autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells, in comparison to corticosteroid injection (CSI). The study was a phase 2/3, four-arm parallel, multicenter, single-blind, randomized, controlled clinical trial with 480 patients with a diagnosis of knee osteoarthritis (Kellgren-Lawrence II-IV).
View Article and Find Full Text PDFPurpose: To establish consensus statements on platelet-rich plasma (PRP) for the treatment of musculoskeletal pathologies.
Methods: A consensus process on the treatment of PRP using a modified Delphi technique was conducted. Thirty-five orthopaedic surgeons and sports medicine physicians participated in these consensus statements on PRP.
To evaluate the clinical response to augmenting ultrasound-guided tenotomy (USGT) with an amniotic membrane (AM) allograft injection. Retrospective study. Subjects underwent either a USGT (N = 16) or a combined USGT plus AM injection (N = 14).
View Article and Find Full Text PDFAutologous biological cellular preparations have materialized as a growing area of medical advancement in interventional (orthopedic) practices and surgical interventions to provide an optimal tissue healing environment, particularly in tissues where standard healing is disrupted and repair and ultimately restoration of function is at risk. These cellular therapies are often referred to as orthobiologics and are derived from patient's own tissues to prepare point of care platelet-rich plasma (PRP), bone marrow concentrate (BMC), and adipose tissue concentrate (ATC). Orthobiological preparations are biological materials comprised of a wide variety of cell populations, cytokines, growth factors, molecules, and signaling cells.
View Article and Find Full Text PDFThe injection of biologic products for musculoskeletal pathologies is an emerging and promising field; however, dubious and unsafe uses for these products are often marketed. The Food and Drug Administration (FDA) has determined the need for varying degrees of regulation for these products for safety and efficacy. These regulations are frequently updated and federally enforced.
View Article and Find Full Text PDFSubchondral bone marrow lesions (BMLs) are areas of disease within subchondral bone that appear as T1 hypointense and T2 hyperintense ill-defined areas of bone marrow on magnetic resonance imaging. The most common bone marrow lesions include subchondral lesions related to osteoarthritis, osteochondral defects, and avascular necrosis. Emerging therapies include autologous biologic therapeutics, in particular mesenchymal stem cells (MSCs), to maintain and improve cartilage health; MSCs have become a potential treatment option for BMLs given the unmet need for disease modification.
View Article and Find Full Text PDFThe purpose is to report preliminary data on clinical response to dehydrated cell and protein concentrate (dCPC) versus corticosteroid (CSI). A single-site prospective, randomized controlled single-blinded trial of patients with knee osteoarthritis. : Pain and function were assessed using a visual analog scale (VAS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Emory Quality of Life (EQOL) measure at 1, 2, 3, 6, 9 and 12 months.
View Article and Find Full Text PDFBackground: Intra-articular injections of human mesenchymal stromal cells (hMSCs) have shown promise in slowing cartilage degradation in posttraumatic osteoarthritis (PTOA). Clinical use of cell therapies for osteoarthritis has accelerated in recent years without sufficient scientific evidence defining best-use practices. Common recommendations advise patients to avoid nonsteroidal anti-inflammatory drug (NSAID) use before and after cell injection over concerns that NSAIDs may affect therapeutic efficacy.
View Article and Find Full Text PDFMany sports medicine physicians are currently considering introducing regenerative medicine into their practice. Regenerative medicine and the subclassification of orthobiologics are a complicated topic and have produced widely varying opinions. Although there is concern by government regulators, clinicians, scientists, patient advocacy organizations, and the media regarding the use of regenerative medicine products, there is also excitement about the potential benefits with growing evidence that certain regenerative medicine products are safe and potentially efficacious in treating musculoskeletal conditions.
View Article and Find Full Text PDFBackground: Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades.
View Article and Find Full Text PDFSports ultrasound is commonly used by sports medicine physicians to enhance diagnostic and procedural accuracy. This expert consensus statement serves as an update to the 2015 American Medical Society for Sports Medicine recommended sports ultrasound curriculum for sports medicine fellowships. Although written in the context of the American sports medicine fellowship training model, we present a stepwise progression in both diagnostic and interventional sports ultrasound that may be applicable to the broader sports medicine community.
View Article and Find Full Text PDFSports ultrasound is commonly used by sports medicine physicians to enhance diagnostic and procedural accuracy. This expert consensus statement serves as an update to the 2015 American Medical Society for Sports Medicine recommended sports ultrasound curriculum for sports medicine fellowships. Although written in the context of the American sports medicine fellowship training model, we present a stepwise progression in both diagnostic and interventional sports ultrasound that may be applicable to the broader sports medicine community.
View Article and Find Full Text PDFPurpose: The aim of this study is to evaluate the outcomes of autologous microfragmented adipose tissue (MFAT) injection in elderly patients with knee osteoarthritis (OA). We hypothesized that MFAT knee infiltration for the treatment of knee OA would yield good clinical results out to two years follow-up.
Methods: Multi-centric, international, open-label study conducted by orthopedic surgery, and/or regenerative medicine facilities utilizing patient registries.
Biologics are a growing field that has shown immense promise for the treatment of musculoskeletal conditions both in orthopedic sports medicine and interventional pain management. These procedures utilize injection of supraphysiologic levels of platelets and growth factors to invoke the body's own inflammatory cascade to augment the healing of many bony and soft tissue conditions. While many patients improve with conservative care, there is a need to address the gap between those that improve with rehabilitation alone and those who ultimately require operative management.
View Article and Find Full Text PDFEmerging autologous cellular therapies that utilize platelet-rich plasma (PRP) applications have the potential to play adjunctive roles in a variety of regenerative medicine treatment plans. There is a global unmet need for tissue repair strategies to treat musculoskeletal (MSK) and spinal disorders, osteoarthritis (OA), and patients with chronic complex and recalcitrant wounds. PRP therapy is based on the fact that platelet growth factors (PGFs) support the three phases of wound healing and repair cascade (inflammation, proliferation, remodeling).
View Article and Find Full Text PDFThe knee joint is one of the most frequently injured joints in the body, and the resulting injury may often lead to the presence of a bloody effusion, or hemarthrosis. The acute management of this condition can have long-lasting implications, and may ultimately result in the early onset of osteoarthritis in this population. Heme, a breakdown product of erythrocytes, and associated pro-inflammatory mediators, are known to have deleterious interactions with cartilage and synovium.
View Article and Find Full Text PDF