Fresh osteochondral grafting in the United States: the current status of tissue banking processing.

The use of musculoskeletal allografts has become increasingly popular among surgeons. The purpose of this review is to highlight the procurment and delievery process of fresh osteochondral allografts in the United States. The four distributors of fresh osteochondral allografts in the United States were contacted. Surveys containing quantitative and qualitative sections concerning the procurement and processing of osteochondral allograft tissue were obtained. Our results showed an average of 13 ± 4.24 years of experience with osteochondral allografts. The average donor age ranged from 13.5 ± 3 to 37.5 ± 5 years, with an average age of 27 ± 2.83 years. All donors were between ages 12 and 45 years old. The percentage of screened donors that were accepted for allograft transplant was consistent at 70-75% for 3 out of the 4 tissue banks. The percentage of grafts that expire without implantation ranged from 20% to 29%. Maximum shipping time varied between 24 and 96 hours. Each tissue bank used its own proprietary storage medium. The time from donor death to the harvest of allograft tissue was < 24 hours. The most commonly requested osteochondral allograft tissue for all banks was the medial femoral condyle. The market share of fresh allografts is as follows: Joint Restoration Foundation (JRF) 59.9%, Muskuloskeletal Transplant Foundation (MTF) 15.3%, LifeNet Health (LN) 14.5%, and Regeneration Technology Incorporated (RTI) 10.2%, with approximately 4700 fresh allografts distributed in 2018. This compiled data from the four tissue banks that supply fresh osteochondral allograft in the United States  provides important background information for patients and orthopaedic surgeons.

A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol.

BACKGROUND: Osteoarthritis (OA) is a highly debilitating joint disease that causes progressive, irreversible damage to articular cartilage. OA takes a massive toll on society that has grown in recent decades, but no therapy has been shown to halt or reverse the progression of the disease. The critical need for better treatments and increased interest cellular therapies has spawned a new generation of "minimally manipulated" cell treatments. Autologous adipose tissue injections are among the most controversial of these new treatments. Despite a lack of clinical evidence, adipose tissue injections are often marketed as "stem cell" injections with wide-ranging regenerative benefits. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA. METHODS: This is a prospective, single-center, parallel-group, randomized, controlled trial. Participants (n = 54) will receive either a single intra-articular, ultrasound-guided injection of autologous adipose tissue or a single intra-articular, ultrasound-guided injection of HA (1:1 ratio). Outcome data will be obtained at baseline, week-6 and month-6. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain domain (WOMAC-A) will be used as the primary outcome measure. Secondary clinical outcome measures include WOMAC (full), clinical anchors (pain, function, and stiffness), and the 29-point Patient-Reported Outcomes Measurement Information System (PROMIS®) profile. We will also take synovial fluid samples and assess sway velocity using a force plate, as well as analyze excess/discard adipose tissue to gain a better understanding of how intra-articular adipose tissue injections influence the biochemical environment of the joint. DISCUSSION: Given the widespread use of intra-articular fat injections in the United States, it is critical that randomized, controlled human studies evaluating efficacy and biological activity be performed. This study is the first step in addressing this unmet need, but it is not without limitations. The most notable limitations of this study are its small size and lack of blinding, which predisposes the study to both investigator and participant bias. TRIAL REGISTRATION: NCT03242707 // HS-17-00365 // Registration Date (First Posted): August 8, 2018.

The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics.

PURPOSE OF REVIEW: This review provides an update on the current status of platelet-rich plasma (PRP). Topics covered include the current regulatory environment, economic outlook, and current clinical evidence. RECENT FINDINGS: The global PRP market is expected to grow to between 380 million and 4.5 billion (USD) over the next 5-10 years. The cost of a single treatment, which is not covered by most insurance, is roughly $500-$2500, with patients often returning for additional treatments. While PRP is not 'FDA-approved', it can be legally offered in the clinic 'off-label' in the USA for a myriad of musculoskeletal indications. Recently published meta-analyses have demonstrated statistically significant improvements that, in some cases, suggest that PRP may have clinically meaningful effects. However, given the fact that clearance is not synonymous with approval, PRP is a costly treatment not covered by insurance, and clinical trials have not demonstrated definitive efficacy, we recommend informing patients when providing PRP 'off-label'.

New techniques in allograft tissue processing.

With the increasing reliance on tissue allografts in orthopedic reconstructive and sports surgery, there is a realistic concern on behalf of both the surgeon and the patient as to the safety of these implanted tissues and the possibility of disease transmission. New Food and Drug Administration guidelines in association with independent agency scrutiny have served to decrease this risk in light of recent publicized reports of infection transmission associated with allograft use. In addition, tissue banks are constantly developing new proprietary techniques for allograft processing and sterilization. However, clinical studies are needed to validate disinfection efficacy and to evaluate the effect of these processes on tissue structural properties. This article serves as a review of historical disease transmission, current governmental and nongovernmental tissue regulations, and specific processing techniques used by tissue banks.