The Effect of Femoral Head Size on Groin Pain in Total Hip Arthroplasty.

BACKGROUND: Although increased femoral head size reduces the risk of instability in total hip arthroplasty (THA), it may lead to iliopsoas irritation and increased anterior groin pain. The purpose of this study is to compare outcomes between non-modular dual-mobility (NDM) implants and small (≤32 mm) and large (≥36 mm) fixed-bearing (FB) constructs. METHODS: A retrospective review of all primary total hip arthroplasties from 2011 to 2021 was conducted at a single, urban academic institution. Patients were separated into 3 cohorts: NDM implant ≤32 mm and FB implant ≥36 mm. Demographics and outcomes such as length of stay, dislocation, and anterior groin pain were assessed. Patients were deemed as having groin pain if they received an iliopsoas injection or had extended physical therapy ordered beyond 3 months postoperatively. RESULTS: There were 178 NDM implants, 936 ≤32-mm FB, and 2,454 ≥36-mm FB implants included. Length of stay significantly differed between the groups (48.4 ± 43.3 vs 63.2 ± 40.6 vs 57.2 ± 38.1 hours; P = .001). Although not statistically significant, the ≥36-mm FB cohort had the highest rate of dislocations (0.6% vs 0.7% vs 0.9%; P = .84). Although no patients with an NDM implant received an iliopsoas injection, 9 patients (0.9%) with a ≤32-mm FB implant and 9 patients (0.4%) with a ≥36-mm implant received an injection (P = .06). However, 18 (10.1%) patients with an NDM implant, 304 (32.5%) patients with a ≤32-mm FB implant, and 355 (14.5%) patients with a ≥36-mm FB implant received extended physical therapy 3 months after surgery (P < .001). CONCLUSION: NDM implants, as well as FB implants with both small and large head sizes are effective at preventing dislocation. NDM implants did not result in an increase in anterior groin pain compared to ≤32-mm and ≥36-mm FB constructs. LEVEL III EVIDENCE: Retrospective cohort study.

ICD-10 Coding Mismatch in Computer and Robotic Assisted Primary Total Hip Arthroplasty.

BACKGROUND: The International Statistical Classification of Disease, 10th Revision Procedural Coding System (ICD-10-PCS) is a granular procedural classification system with the ability to precisely classify types of technology utilized in total hip arthroplasty (THA). However, coding nuances and the rapidly evolving nature of technology may lead to coding inaccuracies. The purpose of this study is to determine the accuracy of ICD-10-PCS coding in computer-navigated and robotic THA and discuss its implications on clinical data. METHODS: The arthroplasty database at a single institution was retrospectively reviewed for all primary computer and robotic assisted THAs performed between October 2015 to November 2020. The type of technology utilized was determined from the surgical record and compared with the ICD-10-PCS codes applied to each procedure. RESULTS: A total of 3721 technology-assisted THAs were identified and reviewed. 87.5% of technology-assisted THAs were coded with the correct type of technology. The most common error in computer navigated THA was the omission of the technology code, while the most common error in robotic assisted THA was the designation of codes for both computer navigation and robotic assistance. CONCLUSION: The granular nature of ICD-10-PCS allows for precise distinction between types of technology-assisted THA. However, rates of coding inaccuracy bring concern for the integrity of this data. The inaccuracy of ICD-10-PCS data is not insignificant and should bring concern for the validity of collective data sets that use it exclusively for its procedural granularity.

Using synthetic peptides and recombinant collagen to understand DDR-collagen interactions.

The discoidin domain receptors, DDR1 and DDR2, are a subfamily of receptor tyrosine kinases that are activated upon binding to collagen. DDR-collagen interactions play an important role in cell proliferation and migration. Over the past few decades, synthetic peptides and recombinant collagen have been developed as tools to study the biophysical characteristics of collagen and various protein-collagen interactions. Herein we review how these techniques have been used to understand DDR-collagen interactions. Using synthetic collagen-like peptides, the GVM-GFO motif has been found to be the major binding site on collagens II and III for DDR1 and DDR2. An X-ray co-crystal structure of the DDR2 DS domain bound to a synthetic collagen-like peptide containing the GVM-GFO motif further provides molecular details of the DDR-collagen interactions. Recombinant collagen has also been used to provide further validation of the GVM-GFO binding motif. Although GVM-GFO has been defined as the minimal binding site, in synthetic peptide studies at least two triplets N-terminal to the essential GVM-GFO binding motif in collagen III sequence are needed for DDR2 activation at high peptide concentrations.

Children and Adults With Rare Diseases Need Innovative Medical Devices.

Rare diseases (RD) affect approximately 30 million Americans, half of whom are children. This study is the first to comprehensively evaluate their medical device needs via a survey of physicians. The study sought to identify and document the presumed unmet diagnostic and therapeutic device needs for RD management; clarify the magnitude of the potential unmet need; and generate meaningful data to inform medical device stakeholders. A cross-sectional nonprobability survey was conducted. The study population was drawn from the membership files of four groups: FDA Medical Devices Advisory Committee, Pediatric Advisory Committee, Pediatric Device Consortia, and National Institutes of Health (NIH) Rare Diseases Clinical Research Network. Only physician respondents with experience or knowledge regarding RD were eligible. Among eligible respondents, 90% confirmed the need for innovative devices to care for people with RD. Over 850 device needs were identified for 436 RD, with 74% of needs related to children. Pediatric physicians (OR = 2.11, 95% CI 1.01-4.39, P = 0.046) and physicians with more RD experience reflected greater dissatisfaction with existing devices (OR = 4.49, 95% CI 2.25-8.96, P < 0.0001). Creation of entirely new devices is the top recommendation for mitigating needs. This study demonstrates a major public health need for innovative medical devices to care for children and adults with RD. FDA and NIH support and seek opportunities to accelerate device development for these vulnerable patients.

Management of an Unusual Periprosthetic Giant Cell Tumor of Bone of the Proximal Tibia.

Giant cell tumor of bone is a relatively rare type of bone tumor, accounting for approximately 4.9% to 9% of all primary osseous neoplasms.1 Management options include intralesional curettage, or more uncommonly, wide resection. This process is then followed by reconstruction with bone graft or bone cementation. We present a case of giant cell tumor of bone adjacent to the tibial component of a preexisting total knee arthroplasty, treated with extensive curettage, argon beam coagulation, polymethyl methacrylate cementation with strut reinforcement, and mesh reconstruction of the extensor mechanism. Twenty months after treatment, the patient was recurrence free with a stable prosthesis and had return to functional activity. We report this treatment modality as a potentially effective method of approaching this rare orthopaedic entity.

Past, present, and future regulatory aspects of ventricular assist devices.

The development of ventricular assist devices (VADs) for the treatment of heart failure has been ongoing since the National Heart Lung and Blood Institute (NHLBI) initiated the artificial heart program in 1964. The primary goal was to develop VADs and total artificial hearts for both temporary (short-term) and long-term use. Due to a small target population and the inability to blind patients and clinicians, the Food and Drug Administration (FDA) has recognized the challenges of conducting trials with these invasive devices. In an effort to address those challenges, FDA has accepted a variety of clinical trial designs to collect the data required to evaluate safety and effectiveness data in different patient groups. This article will provide a detailed discussion of the past, present, and future FDA regulatory considerations for VADs.

FDA's perspectives on cardiovascular devices.

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

Food and Drug Administration's perspectives on pediatric cardiac assist devices.

Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients. However, because of the larger size of the approved devices, many pediatric patients are underserved by this approach. Currently, several cardiac assist devices intended for use in pediatric patients are being developed. FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application. Pediatric device development is challenging and early communication with FDA to develop an appropriate regulatory and scientific pathway for device submission is advised and warranted. This early interaction can facilitate the development of a small but necessary trial for these life-sustaining pediatric cardiac assist devices.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Pediatric circulatory support: an FDA perspective.

The Department of Health and Human Services, at the direction of Congress, has recently begun to address concerns regarding the development of medical devices designed specifically for the pediatric population, including devices for pediatric mechanical circulatory support, as evidenced by the National Institutes of Health's (NIH) funding of several development contracts. Food and Drug Administration (FDA) approval for marketing of these devices will typically follow either of two regulatory pathways: the Humanitarian Device Exemption (HDE) or the Premarket Application (PMA). An HDE is limited both in the extent of clinical use and economic benefit to the manufacturer, but does not require data derived from a clinical trial for market approval. A PMA allows for use in a larger patient population and offers economic benefit for the manufacturer; it does, however, almost always necessitate data derived from a clinical trial. The HDE and PMA require demonstration of a reasonable assurance of safety. In addition, an HDE requires a demonstration of probable benefit, whereas a PMA requires a demonstration of a reasonable assurance of effectiveness. The evidence that can be used to support an HDE or a PMA approval may include both preclinical and clinical data. Types of preclinical tests needed depend upon the device design and its intended use, because circulatory support devices are all unique.