Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
NCT ID: NCT00316121
Last Updated: 2011-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2006-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
HEALOS and Leopard Cage
Placement in interbody space
2
Leopard Cage and Autograft
Placement in the interbody space
Interventions
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HEALOS and Leopard Cage
Placement in interbody space
Leopard Cage and Autograft
Placement in the interbody space
Eligibility Criteria
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Inclusion Criteria
* Male or female 18 to 70 years of age (inclusive)
* Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1
Exclusion Criteria
* Greater than Grade II spondylolisthesis
* Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy \[IDET\] are allowed)
* Insulin-dependent diabetes mellitus
* Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study
18 Years
70 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
OTHER
Responsible Party
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Advanced Technologies and Regenerative Medicine, LLC
Locations
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Little Rock, Arkansas, United States
Beverly Hills, California, United States
Brandon, Florida, United States
Jacksonville, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Annapolis, Maryland, United States
Billings, Montana, United States
Williamsville, New York, United States
Norwood, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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05-HEALOS-01
Identifier Type: -
Identifier Source: org_study_id
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