University of Colorado Anschutz Medical Campus

Spine Clinical Trials: Advancing Treatment for Spine Conditions

Welcome to the University of Colorado Department of Orthopedics' Spine Clinical Trials, where we are dedicated to advancing treatment options for spine conditions. Through our rigorous research and cutting-edge clinical trials, we aim to improve the lives of individuals affected by spine conditions. Join us as we pave the way for innovative therapies and enhanced patient care in spine health.

With a strong focus on innovation and patient-centric care, the University of Colorado Department of Orthopedics is at the forefront of Spine Clinical Trials. Our multidisciplinary team of experts is actively engaged in pioneering research to advance the treatment options for various spine conditions. By combining our expertise, state-of-the-art facilities, and collaborative partnerships, we are committed to improving outcomes and transforming the field of spine health. Join us on this journey as we strive to make a meaningful impact in the lives of individuals suffering from spine conditions through our groundbreaking Spine Clinical Trials.

Clinical Trials

Open access database of standing full body radiographs in asymptomatic volunteers

The goal of the research study is to establish baseline skeletal measurements for the “normal” population, including age-related changes. The collected data will be used to generate a database for doctors to use to improve patient care.

Any patient between the age of 40-85 without significant knee, hip, or spinal problems is eligible to enroll in our study. To learn more about the skeletal system and the changes one may experience over time, the study is employing new X-ray technology, EOS. The radiation dose from an EOS scan is about half of the radiation dose of a standard X-ray and can be done while standing. This allows for the study of whole-body alignment in one radiograph. This would replace the standard technology which would require several x-rays of each body part.

Compensation: None

Contact: Jiandong Hao,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu

PI: Dr. Christopher J. Kleck

Sponsor: University of Colorado, Denver

ClinicalTrials.gov Identifier: NCT03076658

1-Open access database of standing full body radiographs in asymptomatic volunteers

Non-invasive evaluation of upper and lower body function with Showmotion

The study is enrolling people of various ages (18-65 years old) without significant knee, hip, or spinal problems to get a non-invasive Showmotion measurement. It is crucial to understand joint and body kinematics and muscle activity in clinical settings, which is relevant to identify issues related to the spine, and the upper and lower limbs due to injury.

This study will establish baseline shoulder, hip, knee, and spine kinematics and muscle activity from 60 healthy volunteers. The collected data will be used to generate a database for doctors to use to improve patient care.

Compensation: $25

Contact: Aubrie Nuccio,
Phone: 303-794-7457,
Email: aubrie.nuccio@cuanschutz.edu

PI: Dr. Vikas Patel

Sponsor: This research is not being sponsored by any grant funding. This study device is loaned to us at no cost by NCS company.

ClinicalTrials.gov Identifier: NCT04137835

Non-invasive evaluation of upper and lower body function with Showmotion

Lower-Extremity Bony Alignment and Body Habitus Using EOS

This study is enrolling people of various ages (from 20-80). The overall objectives of this project are to investigate functional whole-body bone alignment and body build in three functional positions including sitting, standing, and standing with an extended back. The specific aims are to collect data from x-rays from healthy participants and patients with spinal fusion or total knee or total hip replacement. The collected data will be used to compare differences in the participants. This study is designed for the researcher to learn more about the normal spine and lower extremity function that can be used to improve the ability of total joint replacement to restore normal function.

Compensation: $50

Contact: Jiandong Hao,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu

PI: Dr. Vikas Patel

Sponsor: University of Colorado/Denver University.

Lower-Extremity Bony Alignment and Body Habitus Using EOS

Analysis of prognostic cell signaling factors in Adolescent Idiopathic Scoliosis

The goal of this study is to learn about scoliosis. Scoliosis is a curve in the backbones. This study will try to find markers in the blood that can be used in the future to predict whether or not a spine curve will get worse over time in patients aged 13 and under with diagnosed Adolescent Idiopathic Scoliosis. We hope this study will provide doctors with a better understanding of scoliosis and a way to evaluate and treat future patients with scoliosis.

Compensation: $25 per visit

Contact: Jiandong Hao,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu

PI: Dr. Evalina Burger

Sponsor: University of Colorado, Denver

ClinicalTrials.gov Identifier: NCT02315729

M6-C™ 2-Level Artificial Cervical Disc IDE Pivotal Study

Full study title: A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C™ Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy The purpose of this study is to evaluate the safety and effectiveness of the M6-C Artificial Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating patients with neck and/or arm pain and nerve or spinal cord irritation that results from the discs (the spongy part between the bones in your neck called cervical vertebrae) in your spine not working properly.

Compensation: $50.00 per visit for completion of the 3-Month and 6-Month study follow-up visits and $200.00 per visit at the completion of the 12-Month and 24-Month study follow-up visits.

Contact: Aubrie Nuccio,
Phone: 303-794-7457,
Email: aubrie.nuccio@cuanschutz.edu

PI: Dr. Vikas Patel

Sponsor: Spinal Kinetics, Inc.
Research Studies at University of Colorado
ClinicalTrials.gov Identifier: NCT04982835

M6-C™ 2-Level Artificial Cervical Disc IDE Pivotal Study

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

The purpose of this study is to see how a device called the ReActiv8® treats low back pain compared to other standard treatments that are currently recommended for low back pain. The ReActiv8 consists of an implantable pulse generator (IPG) that is typically placed under the skin above the buttocks or in the lower back area. The IPG is a small metal unit about the size of a matchbox that includes a battery and some specialized electronics. Two leads (wires) are placed (one on each left and right side of the spine) and connected to the IPG. The way the IPG works can be adjusted by your study doctor by way of an external programmer who communicates wirelessly with the IPG through the skin. You will start and stop the delivery of electrical stimulation with an external device (Activator) or magnet. Stimulation is delivered (under your control) typically in two daily sessions for 30 minutes each.

This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the U.S. Food and Drug Administration (FDA). It is also approved and being implanted in people in Europe and Australia. Mainstay Medical Limited makes the device.

Compensation: No compensation is available for being in the study, but there may be reimbursement for certain reasonable travel expenses (such as parking at the study doctor’s office) up to a maximum of $550 per year during participation in the study.

Contact: Jiandong Hao,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu

PI: Dr. Vikas Patel

Sponsor: Mainstay Medical

ClinicalTrials.gov Identifier: NCT04803214

A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury

The aims of this study are to assess how an investigational drug called MT-3921 may change your ability to do or not do things, to characterize any change in your symptoms and overall condition, and to evaluate the safety of MT-3921. 72 subjects who are patients with an acute spinal cord injury and are between the ages of 18 and 70 will participate in this Study.

One prior study of MT-3921 in 48 healthy adult male volunteers to examine the safety and amount of MT-3921 in the blood has been completed. MT-3921 was well tolerated with no unanticipated side effects in single doses.

A second prior study of MT-3921 in 3 acute spinal cord injured patients (2 males and 1 female) has been completed to examine the safety and amount of MT-3921 in the blood. MT-3921 was well tolerated with no unanticipated side effects in single doses.

Compensation: $100 per study visit (Visits 7 through 13); up to a total of $700 after completion of the study.

Contact: Jiandong Hao,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu

PI: Dr. Christopher Kleck

Sponsor: Mitsubishi Tanabe Pharma America Inc.

Research Studies at University of Colorado
ClinicalTrials.gov Identifier: NCT04683848

The Synergy Disc To Anterior Cervical Discectomy and Fusion

Full study title: A Multi-Center, Prospective, Historically-Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD)

The purpose of this research study is to evaluate the safety and effectiveness of the investigational Synergy Disc, a device that is not currently on the market in the US, in the treatment of 1-level cervical DDD. The Synergy Disc was developed by a company called Synergy Spine Solutions Ltd. (s3Spine). Information about the company can be found on the company’s website at www.synergy-disc.com
A comparison will be made between surgical results in patients enrolled in this study and surgical results in ACDF patients who were enrolled in a prior study.

Compensation: Paid for each completed study visit except for the day of surgery visit, for a total of up to $500 if all planned study visits are completed through 24 months and an additional $1,000 for all subsequent annual visits through 7 years.

Contact: Aubrie Nuccio,
Phone: 303-794-7457,
Email: aubrie.nuccio@cuanschutz.edu

PI: Dr. Christopher J. Kleck

Sponsor: Synergy Spine Solutions Ltd.
Research Studies at University of Colorado
ClinicalTrials.gov Identifier: NCT04469231

3Spine Lumbar Fusion Real World Evidence Study

Full study title: A Prospective Data Collection Study of Patients Treated with a Single-Level Lumbar Interbody Fusion Stabilized with Pedicle Screws

This research study is being conducted to collect data on the safety and effectiveness of a lumbar interbody fusion procedure. This is the procedure that your surgeon has recommended to treat your condition. This is not an investigational procedure, and no investigational study devices are used in this study. No part of this surgery is investigational in nature. This study will help the sponsor, 3Spine, collect data to further the understanding of the conditions of your back and potential treatment options. This study will enroll between 200 and 250 subjects (including you) in up to 20 centers across the United States. Your participation in the study will be for at least five years. All subjects will be followed for this period so that their outcomes can be monitored and recorded completely.

Compensation: $50.00 in gift cards for the completion of the screening visit and $500.00 in gift cards for the completion of the surgery visit. The surgery day compensation will be distributed after the completion of the 6-week study visit. $100.00 in gift cards at the completion of each of the 6-week, 3-month, and 6-month study visits. $200.00 in gift cards for the completion of the 12-month study visit, and $400.00 in gift cards for the completion of the 24-month study visit. At the 36-month visit, and upon completion of each yearly visit thereafter participant will receive $50.00 in gift cards. This will add up to a total of $1600.00.

Contact: Jiandong Hao and Victoria Li,
Phone: 303-724-7457,
Email: Jiandong.hao@cuanschutz.edu,
Email: Victoria.2.li@ucdenver.edu

PI: Dr. Vikas Patel

Sponsor: 3Spine Management Company, Inc.
Research Studies at University of Colorado
ClinicalTrials.gov Identifier: NCT04823858

Personalized Spine Study Group

This research aims to understand better how patient-specific rods correct surgery. All hardware has received FDA clearance, this is a post-market study. Everyone that will have a patient-specific rod placed in their back during surgery in this hospital has the option to join this study. This study could potentially help define better techniques for future spine surgeries.

Compensation: Compensation isn’t available for participating in this study, $50.00 will be paid for travel expenses for each study visit 1 and study visit 5 after completion. This will add up to a total of $100.00.

Contact: Aubrie Nuccio,
Phone: 303-794-7457,
Email: aubrie.nuccio@cuanschutz.edu

PI: Dr. Christopher J. Kleck

Sponsor: University of Colorado, Denver
Research Studies at University of Colorado
ClinicalTrials.gov Identifier: NCT04601363

Clinical Trials

Synergy Disc” Protocol Number: 110-00001 IRB 20-2357
A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD), Sponsor: Synergy Disc Replacement Ltd.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury,
Protocol Number: MT-3921-A01, Sponsor: Mitsubishi Tanabe Pharma Development

Interested patients can contact:

Contact: Aubrie Nuccio at The Dept of Orthopedics Spine Research Center,
Phone: 720-848-1910,
Email: aubrie.nuccio@cuanschutz.edu

Orthopedics (SOM)

CU Anschutz

Academic Office One

12631 East 17th Avenue

4602

Aurora, CO 80045

303-724-2955

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Spine Clinical Trials: Advancing Treatment for Spine Conditions

Clinical Trials

Orthopedics (SOM)