Status:
COMPLETED
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Lead Sponsor:
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Collaborating Sponsors:
DePuy Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
Eligibility Criteria
Inclusion
- Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
- 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
- Significant disc degeneration at more than two adjacent levels
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00316121
Start Date
April 1 2006
Last Update
March 3 2011
Active Locations (17)
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1
Little Rock, Arkansas, United States, 72205
2
Beverly Hills, California, United States, 90211
3
Brandon, Florida, United States, 33511
4
Jacksonville, Florida, United States, 32204