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

Advanced Technologies and Regenerative Medicine, LLC (ATRM)138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Degenerative Disc Disease

Interventions

HEALOS and Leopard CageDEVICE

Placement in interbody space

Leopard Cage and AutograftDEVICE

Placement in the interbody space

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (17)

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Brandon, Florida, United States

Outcomes

Primary Outcomes

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

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).

Time frame: 24 months

Data from ClinicalTrials.gov

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