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Journal of Long-Term Effects of Medical Implants

Published 4 issues per year

ISSN Print: 1050-6934

ISSN Online: 1940-4379

SJR: 0.184 SNIP: 0.485 CiteScore™:: 1.1 H-Index: 39

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SPECIAL ISSUE: DESIGNING IMPLANT TRIALS
GUEST EDITOR: MOHIT BHANDARI
Preface: Designing Implant Trials in 2010: A Recipe for Success

Volume 19, Issue 3, 2009, 171 pages
DOI: 10.1615/JLongTermEffMedImplants.v19.i3.10
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ABSTRACT

In a recent evaluation of 1017 device trials listed on a clinical trials register (www.clinicaltrials.gov) between 2005 and 2009, only 84 (8.2%) represented orthopedic device evaluations. These device trials notably had few numbers of patients and few centers and represented approximately 7% of drug trials on the same registry. The relatively small proportion of device trials in orthopedics may represent a lack of interest; however, given the device focus of the field, the answer is more likely to be a lack of necessity—historically, regulatory pathways to implant approvals have not required clinical trials and have largely focused on preclinical and early case-series evaluations. The changing landscape of the regulatory environment necessitates a renewed interest in high-quality clinical research. Specifically, randomized trials of implants in orthopedics are poised to become major designs in the future.
Given the general uncertainty in knowledge of regulatory pathways among researchers and health care providers, the current symposium was developed to clarify the design and execution of device trials in a changing regulatory environment. We focus our papers on the Food and Drug Administration (FDA) device classes and regulatory pathways (510K), design challenges in regulatory trials, site audits, and standard operating procedures. In over a decade of conducting trials, we have also realized the critical importance of data-management systems and contract research organizations. Not every clinician, device manufacturer, or researcher planning a randomized trial will have the infrastructure or experience to meet the strict regulatory compliance guidelines for the proper conduct of the trial. Understanding what to look for in a contract research organization is extremely helpful, especially in an environment of limited funding and high expectations.
We hope that the current symposium will provide a broad context to clinical trials of orthopedic devices. Despite the challenges of the current regulatory arena, there has never been a more exciting time to conduct research in our field.

Forthcoming Articles

Transfer of guided emergence profile developed using customized provisional implant restoration and cementation using an abutment replica technique- A case report. Vinay Sivaswamy, Balaji Anand S D, Jacob Mathew Philip, C J Venkatakrishnan, Narasimman M, Helen Mary Abraham, Pavithra B Marijuana use is Associated with Increased Rates of Hip Dislocation and Lower Insurance Reimbursement among THA Recipients Andrew Recker, Chukwuweike Gwam, Erin Kelly, Scott Douglas, Johannes Plate Surface modification of Mg alloy AZ91D using nanopowder mixed EDM for Biodegradable Implant Alok Kumar, Abhishek Singh The history of orthopedics in the long term: from general medicine to medical specialties Pavlos Altsitzioglou, Ioannis Zafeiris, Fotini Soucacos, Pantelis Limneos, Eleftheria Souliotis, Evanthia Mitsiokapa, Theodosis Saranteas, Andreas Mavrogenis COMPARISON OF ROUGHNESS, WETTABILITY AND SCANNING ELECTRON MICROSCOPY FEATURES BETWEEN SANDBLASTED ACID-ETCHED AND OXIDIZED TITANIUM DENTAL IMPLANTS Kshitiz Chhabra, Arvina Rajasekar CORRELATION BETWEEN PRIMARY STABILITY OF DENTAL IMPLANTS AND BONE DENSITY: A RETROSPECTIVE ANALYSIS Padmaja S, Arvina Rajasekar C-Reactive Protein and Erythrocyte Sedimentation Rates after total and unicompartmental knee arthroplasty - less implant equals quicker normalization Kasım Kılıçarslan, Ömer Faruk Naldöven, Enejd Veizi, Şahan Güven, Şahin Çepni, Ahmet Fırat COMPLICATIONS FOLLOWING SHORT FEMORAL NAIL FIXATION FOR INTETROCHANTERIC HIP FRACTURES. A RETROSPECTIVE STUDY Anastasia Vasilopoulou, Antonios Trichonas, Konstantinos Palaiologos, Emmanouel Antonogiannakis, Christos Nikakis, Stavros Angelis, Spyridon Maris, Christos Grekas , Efthimios Karadimas, Alexandros Apostolopoulos FEA: Connector Designs and Pontic Stress Distribution of Fixed Partial Denture Implant-Supported Metal Framework Saja Muhsin, Enas Mohammed, Khalid Bander Design and Frequency Stability Analysis of an Adaptive Neuro-Fuzzy Inference System based Artificial Pacemaker Controller in MATLAB Nader Jafarnia Dabanloo, Asghar Dabiriaghdam, Fereidoon Nooshirvan Rahatabad, Keivan Maghooli Complications following intraosseous injections of calcium phosphate bone cement in Subchondroplasty. Christos Zachariadis, Helen Leligou, Stauros Kourkoulis, Evaggelos Magnisalis, Panayiotis Papagelopoulos, Olga Savvidou The Impact of Patient Characteristics on Outcomes of Surgically Managed Vertebral Osteomyelitis in the United States: Insights from a National Database Study Jennifer Kurowicki, Stuart Changoor, Daniel Coban, Neil Patel, Kumar Sinha, Ki Hwang, Arash Emami ASSOCIATION OF AGE, GENDER AND SITE OF IMPLANT PLACEMENT - AN INSTITUTION BASED RETROSPECTIVE STUDY Harini Sri, Nabeel Ahmed, Keerthi Shasanka
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