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

A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

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.

Inclusion Criteria:

• 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 Criteria:

• 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