Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

Completed · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00316121

Run by

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

People needed

138

Starts

2006-04-01

Last updated by the study team

2011-03-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Brandon, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Annapolis, Maryland, United States
• Study site — Billings, Montana, United States
• Study site — Williamsville, New York, United States
• Study site — Norwood, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Eugene, Oregon, United States
• Study site — Temple, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Spokane, Washington, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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