Jaime L. Bernstein

Cost-Effectiveness Analyses in Orthopaedic Sports Medicine A Systematic Review

Background: As increasing attention is paid to the cost of health care delivered in the United States (US), cost-effectiveness analyses (CEAs) are gaining in popularity. Reviews of the CEA literature have been performed in other areas of medicine, including some subspecialties within orthopaedics. Demonstrating the value of medical procedures is of utmost importance, yet very little is known about the overall quality and findings of CEAs in sports medicine. Purpose: To identify and summarize CEA studies in orthopaedic sports medicine and to grade the quality of the available literature. Study Design: Systematic review. Methods: A systematic review of the literature was performed to compile findings and grade the methodological quality of US-based CEA studies in sports medicine. The Quality of Health Economic Studies (QHES) instrument and the checklist by the US Panel on Cost-effectiveness in Health and Medicine were used to assess study quality. One-sided Fisher exact testing was performed to analyze the predictors of high-quality CEAs. Results: Twelve studies met inclusion criteria. Five studies examined anterior cruciate ligament reconstruction, 3 studies examined rotator cuff repair, 2 examined autologous chondrocyte implantation, 1 study examined hip arthroscopic surgery, and 1 study examined the operative management of shoulder dislocations. Based on study findings, operative intervention in sports medicine is highly cost-effective. The quality of published evidence is good, with a mean quality score of 81.8 (range, 70-94). There is a trend toward higher quality in more recent publications. No significant predictor of high-quality evidence was found. Conclusion: The CEA literature in sports medicine is good; however, there is a paucity of studies, and the available evidence is focused on a few procedures. More work needs to be conducted to quantify the cost-effectiveness of different techniques and procedures within sports medicine. The QHES tool may be useful for the evaluation of future CEAs.

Ear Reconstruction and 3D Printing: Is It Reality?

Purpose of ReviewAutologous reconstruction of microtia, the most common congenital external ear deformity, is one of the more challenging plastic surgical procedures, causing obligatory donor site morbidity and often resulting in suboptimal aesthetic outcomes. Recent advances in the fields of tissue engineering and 3D printing promise to profoundly affect the practice of reconstructive surgery.Recent Findings3D printed guides are already used by reconstructive surgeons during correction of complex anatomic defects. Similarly, the prosthetics industry has benefited from the ability to rapidly prototype customized pieces. Bioprinting, the ability to 3D print living tissue, is an emerging field that may soon allow the possibility of creating autologous cartilage in specific shapes.SummaryIn this review, we explore the numerous ways 3D printing is being employed to address external ear deformity and how, when used in combination with cutting-edge tissue engineering technology, it may finally help us achieve the holy grail of ear reconstruction—an “off-the-shelf” auricular scaffold.

Tissue engineering the human auricle by auricular chondrocyte-mesenchymal stem cell co-implantation

Children suffering from microtia have few options for auricular reconstruction. Tissue engineering approaches attempt to replicate the complex anatomy and structure of the ear with autologous cartilage but have been limited by access to clinically accessible cell sources. Here we present a full-scale, patient-based human ear generated by implantation of human auricular chondrocytes and human mesenchymal stem cells in a 1:1 ratio. Additional disc construct surrogates were generated with 1:0, 1:1, and 0:1 combinations of auricular chondrocytes and mesenchymal stem cells. After 3 months in vivo, monocellular auricular chondrocyte discs and 1:1 disc and ear constructs displayed bundled collagen fibers in a perichondrial layer, rich proteoglycan deposition, and elastin fiber network formation similar to native human auricular cartilage, with the protein composition and mechanical stiffness of native tissue. Full ear constructs with a 1:1 cell combination maintained gross ear structure and developed a cartilaginous appearance following implantation. These studies demonstrate the successful engineering of a patient-specific human auricle using exclusively human cell sources without extensive in vitro tissue culture prior to implantation, a critical step towards the clinical application of tissue engineering for auricular reconstruction.

Abstract 138: Treating Infected Wounds in the Era of Antibiotic Resistance

PURPOSE: We recently described a bioinspired material composed of nanoparticulate mineralized collagen glycosaminoglycan (MC-GAG) that induces efficient osteogenic differentiation of human mesenchymal stem cells (hMSCs) without the addition of exogenous growth factors, thereby suggestive of a promising, growth factorfree, materials-based method for clinically utilizable bone regeneration. We have previously reported that MC-GAG scaffolds autogenously induce BMP receptor signaling via the canonical (Smad1/5) pathway. However, the necessary and sufficient components of this mechanism remain unknown. Our current study evaluates the contribution of the non-canonical (MAP kinase) pathway in MC-GAG induced osteogenesis.

Abstract 129: Fabrication of the First Full-Scale Human Auricular Chondrocyte Derived Ear Scaffold for Clinical Application

PURPOSE: Trauma-induced heterotopic ossification (tHO) is the aberrant growth of ectopic bone in soft tissue, which develops in patients following severe musculoskeletal trauma. Much of HO literature focuses on a related pathology known as fibrodysplasia ossificans progressiva (FOP), which is caused by a hyperactivating mutation in the type I bone morphogenetic protein receptor (T1-BMPR) ACVR1 (ACVR1 R206H). Consequently, emphasis has been placed on developing inhibitors with improved specificity for ACVR1. However, patients who develop tHO do not harbor known ACVR1 mutations, and it is unclear whether emphasis on ACVR1-specific inhibition is beneficial for the treatment of tHO. Here investigate whether any single T1-BMPR is required for tHO, or whether these receptors perform overlapping roles during tHO development. We further evaluate the efficacy of the BMP ligand trap, Alk3Fc, as a broad-spectrum inhibitor of T1-BMP receptors in the treatment and prevention tHO.

Abstract 130: Better Living Through Chemistry

PURPOSE: The body responds to synthetic surfaces on implanted prosthetic devices with an inflammatory foreign body response (FBR), which results in the gradual deposition of a fibrous collagenous capsule. Capsular contracture (CC), the progressive growth and contraction of this peri-prosthetic capsule, is the most common complication of aesthetic and reconstructive breast surgery, affecting up to 47.5% of patients (1). CC causes breast pain, hardening, and deformity and is the most common indication for revision surgery. CC is thought to be due to an excessive FBR, however the etiology and pathophysiology of this process is poorly understood, and CC can occur in the absence of any putative risk factors. As such, there are no clinically approved therapies for prevention or treatment of CC. Rather, the complication is mitigated with re-operation and capsule excision, which often necessitates implant removal and replacement. Herein we altered the surface chemistry of silicone implants with Sigilon’s proprietary anti-inflammatory molecules, E9 and RZA15. These compounds are biocompatible small organic molecules which are covalently grafted to the surface of the implant. They are designed to reduce immune cell adhesion to the implant, leading to a truncated FBR and reduced fibrosis.

Abstract 15. Better Living through Chemistry: A Novel Breast Implant Surface Coating Significantly Reduces Peri-Prosthetic Capsule Formation

M oday, M arch 7, 2017 PURPOSE: Restoration of breast sensation following breast reconstruction is an evolving part of the reconstructive paradigm. Although spontaneous recovery of sensation has been reported following mastectomy, surgeons are advocating for innervated reconstructions using neurotization at the time of autologous reconstruction. In an effort to further elucidate the evidence basis for nerve coaptation, a meta-analysis of the literature was undertaken.

The Early Impact of an Administrative Processing Fee on Manuscript Submissions at The Journal of Bone & Joint Surgery

BACKGROUND There was a dramatic increase in the volume of manuscripts submitted to The Journal of Bone & Joint Surgery (JBJS) between 2009 and 2012. This resulted in increased journal administrative costs. To offset this financial burden, in May 2013, JBJS started charging authors an administrative processing fee at the time of submission. The purpose of this study was to assess the impact of the administrative fee on the volume and characteristics of manuscripts submitted to JBJS. METHODS Our analysis included 866 manuscripts submitted to JBJS between November 2012 and November 2013. We compared manuscripts submitted 6 months prior to fee implementation and prior to the announcement (denoted as the baseline group), in the several months prior to fee implementation but after the fee implementation announcement (denoted as the fee announcement group), and in the 6 months after fee implementation (denoted as the fee implementation group). Manuscripts were reviewed for institutional and author demographic characteristics, as well as for general study characteristics. RESULTS In the first full calendar year (2014) after the implementation of the fee, the annual volume of submissions to JBJS declined by 33.5% compared with the annual submission volume in 2010 to 2012. In a comparative analysis, the geographical region of origin (p = 0.003), level of evidence (p < 0.0001), funding, and specialty differed between the 3 submission periods. However, subgroup analyses demonstrated that differences were attributable to the fee announcement group and that there were few important differences between the baseline and fee implementation groups. Reporting of funding information improved significantly between the baseline and fee implementation groups; in the post-fee implementation period, studies were more likely to have declared no external funding source (p = 0.001). CONCLUSIONS The administrative processing fee at JBJS has been associated with a decrease in submission volume, but, overall, there has not been a change in the characteristics of studies submitted. However, decreased overall volume implies a decrease in the absolute number of high-level studies submitted to the journal. Administrative processing fees at high-volume journals may be a financially viable way to offset high administrative costs without substantially changing the characteristics of submitted articles.

Innovative 3D Collagen Microsphere Scaffold (MSS) Promotes Robust Cellular Invasion

METHODS: Utilizing Kepler’s conjecture of sphere packing, which states that the arrangement of spheres in a 3D space has a density of 74%, we fabricated 7 mm microsphere scaffolds (MSS) with a regular arrangement of density gradients. Type I collagen microspheres (1%, 0.6% or 0.4%), ranging 50 to 150 μm in diameter, were manufactured via an oil emulsion technique. MSS were fabricated by encasing microspheres of varying collagen density into collagen bulk of varying density (0.3%, 0.2% or 0.6%), so that 74% of the scaffold’s volume was comprised of microspheres and 26% of bulk collagen. MSS underwent thermal gelation at 37°C for 1 hour. Nonmicrosphere-containing 1% or 0.3% collagen scaffolds were fabricated as controls. Scaffolds were implanted subcutaneously in the dorsa of 8 week old wild-type mice and harvested for histological analysis after 7 or 14 days.