Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
NCT00589797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376
Last updated 2018-12-07
Summary
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.
Conditions
- Degenerative Disc Disease
Interventions
- DEVICE
-
Activ-L Artificial Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
- DEVICE
-
ProDisc-L Total Disc Replacement or Charité Artificial Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Sponsors & Collaborators
-
Aesculap Implant Systems
lead INDUSTRY
Principal Investigators
-
Rolando Garcia, M.D. · Orthopedic Care Center
-
James J Yue, M.D. · Yale University
-
Dom Coric, M.D. · Carolina Neurosurgery and Spine Associates
-
Steven Dennis, M.D. · Hoag Memorial Hospital Presbyterian
-
Federico P. Girardi, M.D. · Hospital for Special Surgery, New York
-
Mick Perez-Cruet, M.D. · Michigan Head and Spine Institute
-
Harel Deutsch, M.D. · Rush University Medical Center
-
Glenn Buttermann, M.D. · Midwest Spine Institute
-
Dzung Dinh, M.D. · Neuroscience Education and Research Foundation
-
Vikas Patel, M.D. · University of Colorado, Denver
-
Christopher Ames, M.D. · University of California, San Francisco
-
John Regan, M.D. · St. John's Hospital and Health Center
-
Andrew Dailey, M.D. · University of Utah Medical Center
-
Darren Bergey, M.D. · Rancho Specialty Hospital
-
Brian Dalton, M.D. · Hamot Medical Center
-
Scott Leary, M.D. · Scripps Memorial Hospital La Jolla
-
David Hart, M.D. · University Hospitals Cleveland
-
Antonio Castellvi, M.D. · Foundatin for Orthopaedic Research and Education
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2012-12-31
- Completion
- 2017-01-31
Countries
- United States
Study Locations
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