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

Phase 3

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: HEALOS and Leopard Cage; Device: Leopard Cage and Autograft

• Registration Number: NCT00316121
• Lead Sponsor: Advanced Technologies and Regenerative Medicine, LLC (ATRM)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Primary Completion: 2010-01
• Results First Submitted: 2011-01-19
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-08
• Last Update Submitted: 2011-02-08
• Results First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	HEALOS and Leopard Cage	-
2	Leopard Cage and Autograft	-

Primary Outcome Measures

Name	Time	Method
Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)	24 months	Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).