Evaluation of Commercially Available Knee Cartilage Restoration Techniques Stratified by FDA Approval Pathway

2021 ◽  
pp. 036354652110372
Author(s):  
Andrew Scott Gudeman ◽  
Betina B. Hinckel ◽  
Lasun Oladeji ◽  
Taylor E. Ray ◽  
Wayne Gersoff ◽  
...  
Keyword(s):  
United States ◽  
Cartilage Repair ◽  
The United States ◽  
Regulatory Pathway ◽  
Knee Cartilage ◽  
Level Of Evidence ◽  
Regulatory Pathways ◽  
Levels Of Evidence ◽  
Pubmed Database ◽  
Level 1

Background: Commercially available products used in knee cartilage reconstructive and restorative surgical practices fall under unique US Food and Drug Administration (FDA) regulatory pathways that determine the level of evidence required to market each product. Purpose: To evaluate the levels of evidence in the literature supporting commercially available cartilage repair procedures stratified by FDA regulatory pathway (section 351 vs section 361 of “Human Cells, Tissues, and Cellular and Tissue-Based Products” [HCT/P] in the Code of Federal Regulation) with the hypothesis that products requiring approval under a stringent regulatory pathway (351 HCT/P) have higher levels of evidence in the literature supporting use and that products with a less stringent regulatory pathway (361 HCT/P) have a higher number of products available for use in the United States. Study Design: Systematic review; Level of evidence, 4. Methods: A search of the PubMed database was performed to identify all peer-reviewed articles pertaining to either allograft or autologous cartilage repair technologies. Predefined inclusion and exclusion criteria were used to find clinical, preclinical, and laboratory studies while excluding duplicates, systematic reviews, and products not available in the United States. Articles were categorized by regulatory pathway (351 and 361 HCT/P), and variables including publication year, type of publication, level of evidence, and number of publications were analyzed. Results: After application of predefined criteria, 470 of 1924 articles were included in this study. The 351 HCT/P group was composed entirely of autologous chondrocyte implantation (ACI) technology; 94% of the 361 HCT/P group was composed of osteochondral allografts (OCA). The articles regarding 351 HCT/P were more likely to be clinical in nature than the articles on 361 HCT/P (80% vs 48%, respectively; P = .0001) and entailed significantly more level 1 studies (25 vs 0, respectively; P < .0001). Twice as many articles in the 351 HCT/P group were published in the American Journal of Sports Medicine compared with the 361 HCT/P group (71 vs 38, respectively; P = .18). Conclusion: Both ACI and OCA have robust evidence supporting their use, whereas the remaining regulated products have little or no supporting evidence. Technologies regulated by 351 HCT/P were more likely to be level 1 clinical studies and published in the highest impact journal. The 361 HCT/P pathway regulated many more products, with fewer articles supporting their use.

scholarly journals Postoperative Lyme Arthritis in the Orthopaedic Patient

2019 ◽  
Vol 11 (4) ◽  
pp. 350-354
Author(s):  
Matthew C. Hess ◽  
Zachary Devilbiss ◽  
Garry Wai Keung Ho ◽  
Raymond Thal
Keyword(s):  
United States ◽  
Lyme Disease ◽  
Postoperative Complication ◽  
Joint Pain ◽  
English Language ◽  
The United States ◽  
Lyme Arthritis ◽  
Level Of Evidence ◽  
Pubmed Database ◽  
Level 3

Context:Lyme disease is the most common tick-borne illness in North America and Europe, and Lyme arthritis is a frequent late-stage manifestation in the United States. However, Lyme arthritis has rarely been reported as a postoperative complication.Evidence Acquisition:The PubMed database was queried through June 2018, and restricted to the English language, in search of relevant articles.Study Design:Clinical review.Level of Evidence:Level 3.Results:A total of 5 cases of Lyme arthritis as a postoperative complication have been reported in the literature.Conclusion:These cases highlight the importance for providers practicing in Lyme-endemic regions to keep such an infection in mind when evaluating postoperative joint pain and swelling. We propose herein an algorithm for the workup of potential postoperative Lyme arthritis.Strength of Recommendation Taxonomy (SORT):C

Identifying Current Driver Rehabilitation Practices for Clients With Physical Impairments

2021 ◽  
Vol 75 (Supplement_2) ◽  
pp. 7512515346p1-7512515346p1
Author(s):  
W. Ben Mortenson ◽  
Brittany Langereis ◽  
Sarah Semeniuk ◽  
Lisa Kristalovich
Keyword(s):  
United States ◽  
Clinical Guidelines ◽  
The United States ◽  
Physical Impairments ◽  
Levels Of Evidence ◽  
Low Levels ◽  
Primary Author

Abstract Date Presented Accepted for AOTA INSPIRE 2021 but unable to be presented due to online event limitations. Currently, there is a lack of clinical guidelines to support clinicians working in driver rehabilitation. This study aimed to identify intervention practices and factors that influence driver rehabilitation recommendations by surveying driver rehabilitation specialists practicing across the United States and Canada. Results revealed both consistencies and inconsistencies in practice, which may be related to jurisdictional differences and relatively low levels of evidence in this area. Primary Author and Speaker: W. Ben Mortenson Contributing Authors: Brittany Langereis, Sarah Semeniuk, and Lisa Kristalovich

scholarly journals Perspectives in Treatments of End-Stage Ankle Arthritis Among Orthopaedic Surgeons

2018 ◽  
Vol 3 (3) ◽  
pp. 247301141877997
Author(s):  
Phinit Phisitkul ◽  
Natalie Glass ◽  
Patrick B. Ebeling ◽  
Sandra E. Klein ◽  
Jeffrey E. Johnson
Keyword(s):  
United States ◽  
The United States ◽  
Total Ankle Replacement ◽  
Ankle Arthritis ◽  
Cross Sectional Survey ◽  
Level Of Evidence ◽  
Cross Sectional ◽  
Orthopaedic Surgeons ◽  
Ankle Replacement ◽  
End Stage

Background: This study aimed to assess the preferred operative treatment for patients over the age of 60 with end-stage ankle arthritis and perspectives on total ankle replacement (TAR) among American Orthopaedic Foot & Ankle Society (AOFAS) members. Associated factors were analyzed for potential contraindications among members with different levels of experience. Method: A questionnaire containing 6 questions was designed and sent to 2056 members of the AOFAS. Responses were received from 467 orthopaedic surgeons practicing in the United States (76%), Canada (5%), and 26 other countries (20%). Participants were grouped for response comparisons according to country as well as experience level. Differences in contraindications were compared using χ2 tests or exact tests. Results: Respondents practicing in the United States and surgeons who perform 11 or more TARs per year tended to recommend operative treatments favoring TAR and displayed recognition of its increasing role ( P < .05). Overall, respondents felt that 41% of typical patients over 60 years old with end-stage arthritis would be best treated with TAR. Talus avascular necrosis, morbid obesity (body mass index >40 kg/m2), and poorly controlled diabetes with neuropathy were most recognized as the absolute contraindications to TAR. Surgeon’s experience affected the consideration of these clinical factors as contraindications. Conclusions: Total ankle replacement has a substantial and increasing role in the treatment of end-stage ankle arthritis in patients over the age of 60. Absolute and potential contraindications of the procedures were indicated from a cross-sectional survey of AOFAS members. Surgeons more experienced with total ankle replacement felt more comfortable employing it in a wider range of clinical settings. Level of Evidence: Level III, therapeutic.

FDA Regulatory Pathways for Knee Cartilage Repair Products

2008 ◽  
Vol 16 (4) ◽  
pp. 202-207 ◽  
Author(s):  
David W. Levine ◽  
Laura Mondano ◽  
Michael Halpin
Keyword(s):  
Cartilage Repair ◽  
Knee Cartilage ◽  
Regulatory Pathways

Adverse Staff Health Outcomes Associated with Endoscope Reprocessing

2013 ◽  
Vol 47 (2) ◽  
pp. 172-179 ◽  
Author(s):  
Elane Gutterman ◽  
Lindsay Jorgensen ◽  
Amber Mitchell ◽  
Sherry Fua
Keyword(s):  
United States ◽  
Health Outcomes ◽  
Health Workers ◽  
The United States ◽  
Adverse Outcomes ◽  
Healthcare Personnel ◽  
Health Administration ◽  
Adverse Health ◽  
Adverse Health Outcomes ◽  
Pubmed Database

Abstract There are occupational challenges associated with cleaning, disinfecting, storing, and transporting flexible endoscopes. Although the Occupational Safety and Health Administration (OSHA) has set standards to protect the safety of health workers in the United States, the standards are not specific to endoscope reprocessing, and the general standards that are in place are not fully implemented. Furthermore, adverse staff outcomes may not be fully preventable. To assess the evidence for adverse outcomes in staff associated with endoscope reprocessing, a literature review was performed in the PubMed database for articles on this topic published between Jan. 1, 2007 and March 7, 2012. Eight studies were identified, mainly European, which reported numerous adverse outcomes to healthcare personnel associated with endoscope reprocessing including respiratory ailments and physical discomfort. More scientifically rigorous studies are required to comprehensively describe adverse health outcomes in personnel engaged in reprocessing, particularly in the United States, and examine whether increased automation of the reprocessing process leads to decreased adverse health outcomes for staff.

scholarly journals The Use of COMLEX-USA and USMLE for Residency Applicant Selection

2016 ◽  
Vol 8 (3) ◽  
pp. 358-363 ◽  
Author(s):  
Jeanne M. Sandella ◽  
John R. Gimpel ◽  
Larissa L. Smith ◽  
John R. Boulet
Keyword(s):  
United States ◽  
Strong Association ◽  
The United States ◽  
Medical Licensing ◽  
Usmle Step 1 ◽  
Licensing Examination ◽  
Usmle Step ◽  
Level 1 ◽  
State Medical Boards ◽  
Phi Coefficient

ABSTRACT  The Comprehensive Osteopathic Medical Licensing Examination (COMLEX-USA) and the United States Medical Licensing Examination (USMLE) are recognized by all state medical licensing boards in the United States, and the Federation of State Medical Boards has supported the validity of both examinations for medical licensure. Many osteopathic medical students take both examinations.Background  The purpose of this study was to investigate performance on COMLEX-USA Level 1 and USMLE Step 1 of students from colleges of osteopathic medicine where the majority of students took both examinations.Objective  Data were collected on the entering classes of 2010 and 2011. Relationships between the COMLEX-USA Level 1 and the USMLE Step 1 were quantified using Pearson correlations. The correlation between outcomes on the 2 examinations was evaluated using the phi coefficient. A contingency table was constructed to look at first-attempt outcomes (pass/fail).Methods  Data for 2010 and 2011 were collected from 3 osteopathic medical schools, with 795 of 914 students (87%) taking both examinations. The correlation between first-attempt COMLEX-USA Level 1 and USMLE Step 1 scores was statistically significant across and within all 3 schools. The overall correlation was r(795) = 0.84 (P &lt; .001). Pass/fail status on the 2 examinations was moderately correlated (ϕ = 0.39, P &lt; .01).Results  Our study found a strong association between COMLEX Level 1 and USMLE Step 1 performance. Additional studies to accurately compare scores on these examinations are warranted.Conclusions

Effect of Hospital Characteristics on Performance of Pediatric Digit Replantation in the United States

2020 ◽  
Author(s):  
Neill Y. Li ◽  
Justin E. Kleiner ◽  
Edward J. Testa ◽  
Nicholas J. Lemme ◽  
Avi D. Goodman ◽  
...  
Keyword(s):  
United States ◽  
Pediatric Population ◽  
The United States ◽  
Teaching Hospitals ◽  
Level Of Evidence ◽  
Teaching Status ◽  
Private And Public ◽  
Subsequent Revision ◽  
Privately Owned ◽  
Hospital Characteristics

Abstract Introduction Utilize a national pediatric database to assess whether hospital characteristics such as location, teaching status, ownership, or size impact the performance of pediatric digit replantation following traumatic digit amputation in the United States. Materials and Methods The Kid’s Inpatient Database (KID) was used to query pediatric traumatic digit amputations between 2000 and 2012. Ownership (private and public), teaching status (teaching and non-teaching), location (urban and rural), hospital type (general and children’s), and size (large and small-medium) characteristics were evaluated. Replantations were then divided into those that required subsequent revision replantation or amputation. Fisher’s exact tests and multivariable logistic regressions were performed with p <0.05 considered statistically significant. Results Overall, 1,015 pediatric patients were included for the digit replantation cohort. Hospitals that were privately owned, general, large, urban, or teaching had a significantly greater number of replantations than small-medium, rural, non-teaching, public, or children’s hospitals. Privately owned (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.06–3.06; p = 0.03) and urban (OR: 2.29; 95% CI: 1.41–3.73; p = 0.005) hospitals were significantly more likely to perform replantation. Urban (OR: 4.02; 95% CI: 1.90–8.47; p = 0.0003) and teaching (OR: 2.11; 95% CI: 1.17–3.83; p = 0.014) hospitals were significantly more likely to perform a revision procedure following primary replantation. Conclusion Private and urban hospitals were significantly more likely to perform replantation, but urban and teaching hospitals carried a greater number of revision procedures following replantation. Despite risk of requiring revision, the treatment of pediatric digit amputations in private, urban, and teaching centers provide the greatest likelihood for an attempt at replantation in the pediatric population. The study shows Level of Evidence III.

Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States

Cytotherapy ◽  
2021 ◽  
Vol 23 (3) ◽  
pp. 261-274
Author(s):  
Carolina Iglesias-Lopez ◽  
Mercè Obach ◽  
Antonio Vallano ◽  
Antonia Agustí
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
The European Union ◽  
Regulatory Pathways ◽  
Advanced Therapies

Bibliometric analysis of poison center-related research published in peer-review journals

2015 ◽  
Vol 35 (7) ◽  
pp. 705-712 ◽  
Author(s):  
MB Forrester
Keyword(s):  
United States ◽  
Peer Review ◽  
Medical Toxicology ◽  
The United States ◽  
Poison Center ◽  
Related Research ◽  
Pubmed Database ◽  
Poison Centers ◽  
Number Of Publications ◽  
Advance Knowledge

Poison centers advance knowledge in the field of toxicology through publication in peer-review journals. This investigation describes the pattern of poison center-related publications. Cases were poison center-related research published in peer-review journals during 1995–2014. These were identified through searching the PubMed database, reviewing the tables of contents of selected toxicology journals, and reviewing abstracts of various national and international meetings. The following variables for each publication were identified: year of publication, journal, type of publication (meeting abstract vs. other, i.e. full article or letter to the editor), and the country(ies) of the poison center(s) included in the research. Of the 3147 total publications, 62.1% were meeting abstracts. There were 263 publications in 1995–1999, 536 in 2000–2004, 999 in 2005–2009, and 1349 in 2010–2014. The publications were in 234 different journals. The journals in which the highest number of research was published were Clinical Toxicology (69.7%), Journal of Medical Toxicology (2.2%), and Veterinary and Human Toxicology (2.1%). The research was reported from 62 different countries. The countries with the highest number of publications were the United States (67.9%), United Kingdom (6.5%), Germany (3.9%), France (2.5%), and Italy (2.4%). The number of publications increased greatly over the 20 years. Although the publications were in a large number of journals, a high proportion of the publications were in one journal. While the research came from a large number of countries, the preponderance came from the United States.

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