Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study.

PURPOSE: To compare the clinical outcomes of bone-patellar tendon-bone (BTB) allografts processed via a novel sterilization system with the traditional aseptically processed BTB allografts for anterior cruciate ligament (ACL) reconstruction. METHODS: A total of 67 patients undergoing ACL reconstruction at 6 independent investigation sites were randomized into one of two intervention groups, BioCleanse-sterilized or aseptic BTB allografts. Inclusion criteria included an acute, isolated, unilateral ACL tear, and exclusion criteria included prior ACL injury, multi-ligament reconstruction, and signs of degenerative joint disease. Post-op examiners and patients were blinded to graft type. Patients were evaluated at 6, 12, and 24 months. Clinical outcomes were compared using the IKDC, a KT-1000 knee arthrometer, level of effusion, and ranges of motion (ROM). RESULTS: After randomization, 24 patients received aseptic BTB allografts and 43 patients received BioCleanse-sterilized allografts. Significant improvement in IKDC scores (P \u3c 0.0001) as well as KT-1000 results (P \u3c 0.0001) was noted over the 24-month period for both groups. IKDC or KT-1000 results were not significantly different between groups at any time point. Active flexion ROM significantly improved from pre-op to 24-month follow-up (P \u3c 0.0001) with no difference between groups at any time point. Active extension ROM did not differ significantly between the two groups. CONCLUSIONS: These results indicate that the sterilization process, BioCleanse, did not demonstrate a statistical difference in clinical outcomes for the BTB allograft at 2 years. The BioCleanse process may provide surgeons with allografts clinically similar to aseptically processed allograft tissue with the benefit of addressing donor-to-recipient disease. LEVEL OF EVIDENCE: II

Implantation of a Novel Cryopreserved Viable Osteochondral Allograft for Articular Cartilage Repair in the Knee

Restoration and repair of articular cartilage injuries remain a challenge for orthopaedic surgeons. The standard first-line treatment of articular cartilage lesions is marrow stimulation; however, this procedure can often result in the generation of fibrous repair cartilage rather than the biomechanically superior hyaline cartilage. Marrow stimulation is also often limited to smaller lesions, less than 2 cm2. Larger lesions may require implantation of a fresh osteochondal allograft, though a short shelf life, size-matched donor requirements, potential challenges of bone healing, limited availability, and the relatively high price limit the wide use of this therapeutic approach. We present a straightforward, single-stage surgical technique of a novel reparative and restorative approach for articular cartilage repair with the implantation of a cryopreserved viable osteochondral allograft (CVOCA). The CVOCA contains full-thickness articular cartilage and a thin layer of subchondral bone, and maintains the intact native cartilage architecture with viable chondrocytes, growth factors, and extracellular matrix proteins to promote articular cartilage repair. We report the results of a retrospective case series of three patients who presented with articular cartilage lesions more than 2 cm2 and were treated with the CVOCA using the presented surgical technique. Patients were followed up to 2 years after implantation of the CVOCA and all three patients had satisfactory outcomes without adverse events. Controlled randomized studies are suggested for evaluation of CVOCA efficacy, safety, and long-term outcomes

Imaging of the Rotator Cuff With Optical Coherence Tomography

This study evaluated the utility of optical coherence tomography (OCT) in imaging porcine and human rotator cuff (RTC) tissue, analyzed its effectiveness in identifying clinical pathology, and correlated these findings with histologic examination. Twelve human cadaveric and 6 porcine shoulders were evaluated. Six-millimeter–wide bone sections were harvested from the proximal humerus of each specimen, with each containing the entire enthesis of the respective RTC tendon, as well as 2 cm of tendon medial to the enthesis. Only the supraspinatus tendon was evaluated in the human specimens, whereas the enthesis of multiple RTC tendons were evaluated in the porcine model. All specimens were imaged using OCT and correlated with histologic evaluation. Optical coherence tomography evaluation of macroscopically healthy tissue consistently showed an easily identifiable banding pattern (birefringence) in contrast to a disorganized, homogeneous appearance in grossly diseased tissue. Optical coherence tomography was more effective for qualitative evaluation of RTC tissue, identification of bursal-sided RTC tears, and localization of calcific deposits, whereas intrasubstance tendon delaminations and partial articular-sided tendon avulsion lesions were relatively more difficult to identify. Optical coherence tomography correlated well with histologic evaluation in all specimens. Optical coherence tomography provides high-resolution, subsurface imaging of rotator cuff tissue in real-time to a depth of up to 4 mm with excellent correlation to histology in a cadaveric model. Optical coherence tomography could be an effective adjunctive tool for the identification and localization of rotator cuff pathology. The use of OCT in arthroscopic shoulder surgery potentially provides a minimally invasive modality for qualitative assessment of rotator cuff pathology. This may allow for a decrease in soft tissue dissection, improved qualitative assessment of cuff tissue, and improved patient outcomes

Critical appraisal of the role of glucosamine and chondroitin in the management of osteoarthritis of the knee

Steven J Narvy1, C Thomas Vangsness Jr21Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; 2Department of Orthopaedic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USAAbstract: Osteoarthritis (OA) is the most common musculoskeletal disease in the United States, with rising prevalence. Medical management of OA involves acetaminophen, nonsteroidal anti-inflammatory drugs, and other analgesics, all of which are of variable efficacy and are associated with significant side effects and toxicities. The purpose of this review is to critically evaluate the efficacy of glucosamine and chondroitin, both as single agents and in combination, for the treatment of knee OA. Also evaluated were the level of evidence and funding support of the included articles. Almost every included trial of glucosamine sulfate, glucosamine hydrochloride, and chondroitin sulfate has found the safety of these compounds to be equal to that of placebo, though their therapeutic efficacy in decreasing knee OA pain and improving joint function is variable. Additionally, there are data to support a role of these agents in reducing radiographic progression of knee OA. Industry involvement, however, remains prominent. Further, more comprehensive study by independent researchers free of industry ties is necessary to identify a subset of patients in whom the use of glucosamine and/or chondroitin would be most beneficial. These agents may be safely tried as an initial therapy in select OA patients prior to initiating therapy with nonsteroidal anti-inflammatory drugs, acetaminophen, and other traditional medications.Keywords: glucosamine sulfate, glucosamine hydrochloride, chondroitin sulfate, knee osteoarthritis, nutritional supplement, nutraceutica

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

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.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'

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

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.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'