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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEALOS and Leopard Cage

Device

Placement in interbody space

Leopard Cage and Autograft

Device

Placement in the interbody space

Primary outcomes

Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

Other

Collaborators

DePuy Spine

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
First posted: Apr 20, 2006
Registry last updated: Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed