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| Sponsor: | Aesculap Implant Systems |
|---|---|
| Information provided by: | Aesculap Implant Systems |
| ClinicalTrials.gov Identifier: | NCT00589797 |
Purpose
The purpose of this study is 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 lower (lumbar) spine.
| Condition | Intervention | Phase |
|---|---|---|
|
Degenerative Disc Disease |
Device: Activ-L Artificial Disc Device: ProDisc Total Disc Replacement or Charite Atifical Disc |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease |
| Estimated Enrollment: | 414 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
Device: Activ-L Artificial Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|
Active Comparator: 2
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
Device: ProDisc Total Disc Replacement or Charite Atifical Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
|
The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:
Single level symptomatic disease at L4/L5 or L5/S1.
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Scripps Memorial Hospital La Jolla | |
| La Jolla, California, United States, 92037 | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| Rancho Specialty Hospital | |
| Rancho Cucamonga, California, United States, 91730 | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| St. John's Hospital and Health Center | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale University School of Medicine/New Haven Hospital | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Aventura Hospital and Medical Center | |
| Aventura, Florida, United States, 33180 | |
| University Community Hospital | |
| Tampa, Florida, United States, 33613 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Neurosciences Education and Research Foundation | |
| Peoria, Illinois, United States, 61605 | |
| United States, Minnesota | |
| HealthEast St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Carolinas Healthcare | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Hamot Medical Center | |
| Erie, Pennsylvania, United States, 16507 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: | Rolando Garcia, M.D. | Orthopedic Care Center |
| Principal Investigator: | James J Yue, M.D. | Yale University |
| Principal Investigator: | Dom Coric, M.D. | Carolina Neurosurgery and Spine Associates |
| Principal Investigator: | Steven Dennis, M.D. | Hoag Memorial Hospital Presbyterian |
| Principal Investigator: | Federico P. Girardi, M.D. | Hospital for Special Surgery, New York |
| Principal Investigator: | Mick Perez-Cruet, M.D. | Michigan Head and Spine Institute |
| Principal Investigator: | Harel Deutsch, M.D. | Rush University Medical Center |
| Principal Investigator: | Glenn Buttermann, M.D. | Midwest Spine Institute |
| Principal Investigator: | Dzung Dinh, M.D. | Neuroscience Education and Research Foundation |
| Principal Investigator: | Vikas Patel, M.D. | University of Colorado, Denver |
| Principal Investigator: | Christopher Ames, M.D. | University of California, San Francisco |
| Principal Investigator: | John Regan, M.D. | St. John's Hospital and Health Center |
| Principal Investigator: | Andrew Dailey, M.D. | University of Utah Medical Center |
| Principal Investigator: | Darren Bergey, M.D. | Rancho Specialty Hospital |
| Principal Investigator: | Brian Dalton, M.D. | Hamot Medical Center |
| Principal Investigator: | Scott Leary, M.D. | Scripps Memorial Hospital La Jolla |
| Principal Investigator: | David Hart, M.D. | University Hospitals Cleveland |
| Principal Investigator: | Antonio Castellvi, M.D. | Foundatin for Orthopaedic Research and Education |
More Information
| Responsible Party: | Michael J. Andrews, Aesculap Implant Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00589797 History of Changes |
| Other Study ID Numbers: | ASC-01 |
| Study First Received: | December 26, 2007 |
| Last Updated: | October 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Degenerative Disc |
|
Spinal Diseases Intervertebral Disk Degeneration Bone Diseases Musculoskeletal Diseases |