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Wallis Stabilization System Clinical Trial
Introduction to the Wallis Stabilization System
The Wallis® Posterior Dynamic Stabilization System is a non-fusion, spinal stabilization device that is currently limited by US law to investigational use within the US. The Wallis clinical study is a multi-center, prospective, randomized, active controlled study comparing the safety and effectiveness of the Wallis device to an artificial disc replacement. The artificial disc is an FDA-approved, commercially available implant designed to replace an entire diseased or damaged spinal disc through a surgery called “total disc replacement” (TDR).The Wallis System is designed to treat the pain caused by degenerative disc disease (DDD) by stabilizing the lumbar spine without a fusion procedure.
Study objectives
The primary objective of the Wallis Clinical Study is to demonstrate that the Wallis System is equivalent to total disc replacement for the treatment of mild to moderate degenerative disc disease of the lumbar spine at the L4 – L5 level.Study overview
Approximately 25 medical centers will be enrolling patients into this clinical study to assess the safety and effectiveness of the Wallis System in the treatment of mild to moderate degenerative disc disease of the lumbar spine at the L4 – L5 level.The Study will be randomized so that 50% of the study participants will receive a Wallis Device and 50% will receive a commercially available artificial disc (either the CHARITÉ® or PRODISC-L® artificial disc). Patients will be randomly assigned to receive either surgical option.
Study participants will receive all study related test articles and surgical procedures at no charge.
Study sponsor
Austin, TX based Abbott Spine researches, develops and sells spinal instrumentation in the treatment of degenerative spinal disorders.For more information, please visit us at our website ().
Status
Enrolling PatientsInclusion criteria for Wallis Stabilization System Clinical Trial
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Age 18-60 (inclusive) and skeletally mature.
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Diagnosis of mild to moderate single-level degenerative disc disease at L4-L5 as confirmed by radiography.
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Minimum of six months of failed conservative treatment.
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Pre-operative visual analog (VAS) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain.
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Preoperative baseline Oswestry Disability Index (ODI) score of ≥ 40 on a 100 point scale;
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Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol; and
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Voluntarily signs the Patient Informed Consent.
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Patient is a surgical candidate for an anterior approach to the lumbar spine (< 3 abdominal surgeries).
Exclusion criteria for Wallis Stabilization System Clinical Trial
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The investigator believes that the L1-L2, L2-L3, L3-L4 or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI or discography.
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Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.
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Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score < -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophrectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.
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Congenital lumbar spinal stenosis.
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Bony lumbar stenosis.
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Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI >40 kg/m2).
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A history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (IDET) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels.
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Prior participation in the study of any investigational spinal implant or investigational spinal treatment.
*This is an abbreviated list of inclusion/exclusion criteria. Please contact study centers for a more detailed list of study criteria.
Listing of clinical sites involved in this research
Please contact a hospital near you for additional information on participating in this clinical study:
CaliforniaColorado
Indiana
Illinois
Missouri
North Carolina
Pennsylvania
South Carolina
Wisconsin
More centers that are participating in this clinical trial will be added to this list shortly.
To reach someone at Abbott Spine directly about the Wallis trial, or to inquire about a participating hospital you did not see on the list please contact:
Jose Naveira, Wallis Clinical Project Leader
jose.naveira@abbottspine.com
| California: | |
| Name of center: | Spine Source |
| Primary investigator: | John J. Regan, MD |
| Location: | 120 S.
Spalding Drive, Ste. 400 Beverly Hills, CA 90212 |
| Contact name: | Ryan Elizabeth Homsher, CCRP and Paul Vaca |
| Phone number: | 310-385-8015 and 310-415-4497 |
| Fax number: | 310-385-8040 |
| E-mail: | rescoordinator@spinesource.com |
| Website: | www.spinesource.com |
| Name of center: | Core Orthopaedic Medical Center |
| Primary investigator: | L. Erik Westerlund, MD |
| Sub-investigators: | Timothy A. Peppers, MD & Kiersten L. Gregory, PA-C |
| Location: | Encinitas, CA 92024 |
| Contact name: | Farouk Awad |
| Phone number: | 760-943-6700 |
| Colorado: | |
| Name of center: | Boulder Neurological Associates |
| Primary investigator: | Alan T. Villavicencio, MD  More on this physician |
| Sub-investigator: | Jefferey J. Thramann, MD |
| Location: | Boulder, CO 80504 |
| Contact Name: | Sigita Burneikiene |
| Phone number: | 303-998-0004 |
| Name of center: | Denver Spine |
| Primary investigator: | Gary Ghiselli, MD |
| Co-investigators: | David A. Wong, MD and Sanjay Jatana, MD More on this physician |
| Location: | 7800 East Orchard Road, Suite 100 Greenwood Village, CO 80111 |
| Contact Name: | Mary Shippey, CRC |
| Email: | mary_shippey@yahoo.com |
| Phone number: | 720-560-0685 or 303-783-1300 |
| Indiana: | |
| Name of center: | Fort Wayne Orthopaedics |
| Primary investigator: | Kevin A. Rahn, MD More on this physician |
| Location: | 7601 West Jefferson
Boulevard Fort Wayne, IN 46804 |
| Contact Name: | Chad Badorek, Research Coordinator |
| Phone number: | 260-436-8686 x4278 and 800-566-5659 x4278 |
| E-mail: | cbadorek@fwortho.com |
| Website: | www.fwortho.com/ |
| Pennsylvania: | |
| Name of center: | Lehigh Valley Hospital |
| Primary investigator: | Dr. Jeffrey McConnell, MD More on this physician |
| Location: | Allentown, PA 18103 |
| Contact Name: | Karen Gonzalez, RN, BSN |
| Phone number: | 610-402-1036 |
| Wisconsin: | |
| Name of center: | BayCare Clinic |
| Primary investigator: | Dr. Paul Baek, MD |
| Location: | Green Bay, WI 54311 |
| Contact Name: | Lesley Bitters, CRC |
| Phone number: | 920-288-4398 |
The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research.
This is a listing of industry-sponsored clinical trials that are actively recruiting patients. These clinical trial listings are not edited or peer-reviewed by Spine-health.com.
