Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease
Who May be a Candidate
The study is open to subjects with single-level Degenerative Disc Disease (DDD) of the lumbar spine (L4/L5, or L5/S1), who are 18- to 60-years of age, having obtained skeletal maturity and satisfy all the following primary inclusion criteria:
1. Be diagnosed with symptomatic degenerative disc disease with objective evidence
of lumbar DDD.
2. Have received a minimum of six-months of unsuccessful conservative treatment,
including, but not limited to physical therapy and/or medication.
3. Have a minimum Oswestry Disability Index score of 40/100 and have back pain
at the operative site which is at least 40/100 mm and exceeds the highest (right
or left) leg pain using a visual analog scale.
4. Be a surgical candidate for an anterior approach to the lumbar spine.
A complete inclusion and exclusion criterion appears with information about eligibility, below.
Subjects enrolled in the study will be required to undergo screening for eligibility, undergo the surgical procedure for total disc replacement with an artificial disc. Required follow up visits for evaluation are at 6-weeks, 3-months, 6-months, 12-months, and 24-months after surgery. Certain subjects will also be evaluated 3-years, 4-years, and 5-years after surgery.
Product Being Studied
Aesculap Implant Systems, Inc. is conducting a clinical investigation to learn whether an investigational device called the Activ-L™ Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lumbar spine.
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Clinical Trial Sponsor
This study is financed by Aesculap Implant Systems, Inc., the designer and manufacturer of the Activ-L™ Artificial Disc. This study is being carried out under an Investigational Device Exemption (IDE) from the US Food and Drug Administration.
Official Website: www.aesculapimplantsystems.com
Purpose and Objective
The control devices are the Synthes Spine ProDisc®-L Total Disc Replacement and the DePuy Charité® Artificial Disc that have been approved by the FDA. One of the goals of this study is to see if the Activ-L™ Artificial Disc performs as well as the ProDisc®-L Total Disc Replacement and the Charité® Artificial Disc.
Because this is a randomized study, approximately two out of three subjects will receive the Activ-L™Artificial Disc. Potential benefits of participating in this study include the fact that the study may generate information that leads to the development of improved devices and procedures for the treatment of degenerative disc disease. Future patients may benefit from these treatment improvements.
Since this study involves a procedure for the treatment of degenerative disc
disease, if the procedure is successful it may result in a shorter recovery
time compared with spinal fusion or discectomy, decreased pain, and improved
quality of life as compared to a subject's current condition. However, it cannot
be guaranteed that a subject's condition will improve as a result of participation
in this study and subjects may receive no benefit at all.
Recruiting Locations (United States)
| State | City | Location |
| California | Los Angeles |
John Regan, MD - Century City Doctors Hospital |
| Newport Beach | Steve Dennis, MD - Hoag Memorial Hospital | |
| San Francisco | Christopher Ames, MD - University of California, San Francisco Hospital | |
| Colorado | Denver | Vikas Patel, MD - University of Colorado Health Science Center |
| Connecticut | New Haven | James Yue, MD - Yale New Haven Hospital |
| Florida | Aventura | Rolando Garcia, MD - Aventura Hospital |
| Illinois | Chicago | Harel Deutsch, MD - Rush University Hospital |
| Peoria | Dzung Dinh, MD - OSF St. Francis | |
| Michigan | Detroit | Mick Perez-Cruet, MD - Providence Hospital |
| Minnesota | Minneapolis | Glenn Butterman, MD - St. John's Hospital |
| New York | New York | Federico Girardi, MD - Hospital for Special Surgery |
| North Carolina | Charlotte | Domagoj Coric, MD - Carolinas Medical Center |
| Texas | Dallas | Scott Blumenthal, MD - Texas Back Institute |
Eligibility, Inclusion and Exclusion Criteria
The study is open to subjects with single-level Degenerative Disc Disease (DDD) of the lumbar spine (L4/L5, or L5/S1), who are 18- to 60-years of age, having obtained skeletal maturity, and must satisfy the following inclusion and exclusion criteria.
The study is now being conducted at clinical sites nationwide. For additional
information, or study locations, email your request to AISActivL.us@aesculap.com
ClinicalTrials.gov Identifier: NCT00589797
Study ID Numbers: ASC-01
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject),
Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease
Back Pain Help
This information is not designed to replace a physician's independent judgment about the appropriateness or risks of a procedure for a given patient. Always consult your doctor about your medical conditions or back problem. SpineUniverse does not provide medical advice, diagnosis or treatment. Use of the SpineUniverse.com site is conditional upon your acceptance of our User Agreement
