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Research at Spine Colorado / Clinical Trials

History of Research at SpineColorado | Clinical Trials | Investigational Device Exemption (IDE) Trials | Retrospective Studies | Past and Current Research Activity

History of Research at SpineColorado

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.

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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 numerous book chapters, peer-reviewed journal articles, and white papers. He has also presented his research at a variety of national and international medical conferences.


Clinical Trials

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.

conference roomThe 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:

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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.


Investigational Device Exemption (IDE) Trials:

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 Studies:

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:

  • A Single-Surgeon Study of Selective Osteoprogenitor Cell Retention for Enhancement of Lumbar Spinal Fusion: A Minimum 2-Year Follow-up
  • A Cost Analysis of Allograft Composite Versus Iliac Crest Bone (ICBG) for Graft in Lumbar Spinal Fusion
  • Early Functional Outcomes and Fusion Success Rates of HEALOS Bone Graft Replacement Combined with Autologous Bone Marrow Aspirate
  • Assessment of Success of Fusion Using the CELLECTTM Selective Cell Retention System in One- and Two-Level Transforaminal Lumbar Interbody Fusion
  • The use of autologous platelet-poor plasma as a barrier to prevent ectopic bone formation following lumbar fusion with BMP
  • Preliminary Findings from a Single Site Investigating the Use of Extreme Lateral Interbody Fusion as a Treatment for Adjacent Segment Disease
  • Meta-analysis Comparing Clinical Outcomes of Cervical Total Disc Replacement versus Anterior Cervical Discectomy and Fusion
  • Findings from a Single Site Investigating the Use of Extreme Lateral Interbody Fusion as a Treatment for Degenerative Lumbar Deformity at One Year Follow-up


Past and Current Research Activity

Investigational Device Study Synopsis
Intradiscal rhGDF-5 01 The purpose of this study is to test the safety and performance of Intradiscal rhGDF-5 as an injectable treatment for degenerative disc disease.
Intradiscal rhGDF-5 04 The purpose of this study is to test the safety and performance of Intradiscal rhGDF-5 as an injectable treatment for degenerative disc disease as compared to a placebo.
CerviCore The purpose of this research study is to continue to gather safety and effectiveness information about the CerviCore® Intervertebral Disc, the device under investigation.
CerviCore Continued Access The purpose of this research study is to continue to gather safety and effectiveness information about the CerviCore® Intervertebral Disc, the device under investigation.
Acadia The purpose of this research study is to evaluate a facet implant (study device) that has been designed to replace diseased facet joints.
PreFix The current research study evaluates an investigational medical device called the Prefix B2ATM Peptide Enhanced Ceramic Granules (Prefix) [Bone Void Filler (BVF)] (“Prefix”) for use in spinal fusion surgery.
TLIF/OP-1 This is a research study of two investigational systems with a TLIF surgery to see if they are safe and lead to healing of the back by reducing leg and/or back pain. These systems are called the OP-1 Putty Spinal System and the Autograft Spinal System.
NeoDisc The main purpose of this study is to compare the results of the NeoDisc to the standard of care, ACDF.
XL TDR The main purpose of this study is to compare the results of the NuVasive Lumbar TDR device to literature-reported results of similar devices that have been approved by the FDA to treat disc degeneration.
Superion In this study, the Superion ISS will be compared to the X-STOP IPD which is also inserted during a surgical procedure to help spinal stenosis.
Axial Biotech Researchers want to find out the locations of the genes that may contribute to spinal conditions. Researchers hope to use the information from this study to develop a test that will lead to earlier diagnosis and less invasive (having to go inside the body) treatments for the spinal conditions listed above.
Cellect This study evaluated the efficacy of lumbar fusion using composite graft of allograft bone combined with autologous bone marrow aspirate concentrated intra-operatively using selective cell retention technology.
Neurovision The usefulness of the new automated system for determining pedicle screw placement will be determined by comparing the EMG results from both systems with the surgeon’s operative judgment, with x-ray evidence of screw positioning, and with information regarding your post-operative symptoms.
HEALOS The purpose of this research is to evaluate the rate of bone formation in subjects who receive HEALOS® enriched with osteoprogenitor cells in lumbar fusion and to determine the efficiency of CELLECT in processing mesenchymal bone cells from autologous bone marrow aspirate (BMA) into HEALOS matrix.
Phenotypic and genetic profiling The purpose of this medical research study is to collect and study intervertebral disc tissue that would otherwise be discarded during your back surgery.
Heparin CELLECT This study is being done to determine if lowering the amount of Heparin used in collecting bone marrow will have any effect on the total number of cells in it as well as how it works with the CELLECT™ Mixing System.
Formagraft XLIF This research is being done to obtain information about the use of FormaGraft as a graft substitute versus the other options that are currently available.
Oxiplex Oxiplex®/SP Gel is an experimental device, which may help prevent some of the side effects that can occur after lumbar spine surgery. The study is designed to examine the safety and efficacy of the device.
Formagraft PLF This research is being done to obtain information about the use of FormaGraft as a graft substitute versus the other options that are current available.
EmBrace The purpose of this study is to gather more information about the results of cervical fusion surgery using the Embrace™ device that will be used in combination with cervical fusion surgery.

To view other clinical trials that are currently enrolling new patients, please visit clinicaltrials.gov.












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