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Research at Spine Colorado / Clinical Trials
In 2002, Dr. Jim Youssef started the Research Department at Spine Colorado. His interests in clinical applications in spine surgery led to his participation in clinical trials. As a result, this participation has created an opportunity for pre-medical student internships and allows Dr. Youssef to share new technology and techniques in spine surgery with colleagues at various national medical education meetings. In 2009, Dr. Douglas Orndorff and Dr. Cyril Bohachevsky joined the Research Department as Principal Investigators (PI) for surgical and non-surgical studies, respectively.
Dr. Youssef has participated in spine-related research for more than 15 years. His research has involved cervical total disc replacement, use of bone morphogenetic protein in the lumbar spine, minimally invasive surgical procedures and other various new technology surgical techniques. An important goal in conducting clinical research trials is to give patients a more active role in their healthcare by providing them access to new treatment technology and techniques that would otherwise not be available.
The goal of the Research Department is to generate important and relevant data for the advancement of spine surgery. The outcomes of retrospective reviews and other papers are submitted for publication in peer review journals, and the data generated from clinical trials and independent research projects are presented at national society meetings. Since 2000, Dr. Youssef has published six book chapters, fourteen peer-reviewed journal articles, and one white paper. He has presented his research at numerous nationally-recognized medical conferences.
A clinical trial can be defined in many different ways. Ultimately, clinical trials involve biomedical or health-related research studies of human beings receiving investigational treatment. These studies usually follow a pre-defined protocol. A protocol is the study plan that outlines the terms of the study, the purpose and method of the study and the relevant procedures such as X-ray, MRI/CT and hematology and blood chemistry. Most of the clinical trials that Spine Colorado participates in are called interventional studies. These studies involve research patients under the care of a Principal Investigator (PI), who is responsible for the entirety of the study. They are ultimately responsible for all outcomes related to the clinical trial. The PI delegates some of the study related tasks to a Clinical Research Coordinator (CRC) to oversee the study.
Usually, patients will be randomized to a treatment or other intervention, and their outcomes are measured.
To be eligible to participate in a clinical trial, patients need to meet the inclusion/exclusion criteria for the study. The “inclusion criteria” is a list of factors that the participant has to meet to participate in a clinical trial while the “exclusion criteria” excludes participants from participating in the study. Some of the criteria that participants need to meet are age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. These criteria serve to protect patients and make sure that the appropriate participants are identified.
The participant must sign an informed consent to officially participate in a study. During the consent process, the participant will be informed about key factors of the clinical trial before deciding whether or not to participate. The informed consent process is a continuing process throughout the study to provide relevant study information to participants, along with the risks and potential benefits of the treatment and that the patient is free to withdraw from the study at anytime.
The effectiveness of an investigational device cannot be guaranteed. Therefore, the risks, discomforts or benefits are unknown. In order to ensure proper data collection, participants may need to dedicate time and attention such as trips to the study site for repeat procedures such as X-ray or MRI and completing questionnaires.
Study participants have a required follow-up schedule to adhere to at 6-weeks, 3-months, 6-months, 12-months and 24-months, which are the most important part of a clinical trial. During these visits, information is collected regarding a participant’s progress in the study, how the implanted device compares to the control group and information regarding any new injuries, symptoms or complaints unrelated to the device.
All clinical trials must be conducted in agreement with ethical and legal codes that govern medical practice. Good Clinical Practices (GCP) provides the regulations and requirements that must be met in an investigational study. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR). Under these primary regulations, several codes apply to the use of investigational devices in clinical trials:
21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
21 CFR 50, Protection of Human Subjects, provides the requirements and general elements of informed consent;
21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for institutional review boards (IRBs) that approve clinical investigations protocols;
21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of financial compensation to clinical investigators which is part of FDA’s assessment of the reliability of the clinical data.
21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.
The clinical trial is required to follow a Sponsor outlined protocol study plan that details the study outline to researchers. Throughout the study, participant information is reported at scientific meetings, to medical journals and to various government agencies. The participant’s identifying information is protected according to HIPAA and will never be revealed.
IDE trials involve the use of an investigational device in a clinical study. These trials collect safety and effectiveness data required to support a Sponsor’s Premarket Approval (PMA) application or a Premarket Notification [501(k)] submission to the FDA. Any study that involves a clinical evaluation of an investigational device, unless exempt, requires IDE approval before the study is initiated.
Investigational devices that are not approved for the market must have IDE approval by an institutional review board (IRB) and if the study involves significant risk the FDA must also approve the IDE. The Sponsor is required to label the device for investigational use only and employ a monitor to evaluate each site using the investigational device. The CRC reports the information to the Sponsor regarding the investigational device and the Sponsor must communicate with the FDA regarding the records and reports of participants.
Retrospective chart review studies involve the review of patient charts to compile a database that can be included in several independent research studies at Spine Colorado. These studies will report outcome information such as postoperative radicular leg pain, ectopic bone formation secondary to the use of bone morphogenetic protein and the use of bone marrow aspirate technology in regards to fusion success. These IRB approved studies de-identify patient information in accordance to HIPAA for the use of patient outcomes in these research studies.
The retrospective studies currently underway at Spine Colorado include the following:
To view other clinical trials that are currently enrolling new patients, please visit clinicaltrials.gov.
The pictures displayed in www.spinecolorado.com are images of actual patients and employees who have consented to have their picture in this website.