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

Advanced Technologies and Regenerative Medicine (ATRM)

Status and phase: Completed; Phase 3

Conditions: Degenerative Disc Disease

Treatments: Device: HEALOS and Leopard Cage; Device: Leopard Cage and Autograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00316121

05-HEALOS-01

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

1

Experimental group

Treatment:

Device: HEALOS and Leopard Cage

2

Active Comparator group

Treatment:

Device: Leopard Cage and Autograft