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

February 8, 2011 updated by: Advanced Technologies and Regenerative Medicine, LLC (ATRM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Beverly Hills, California, United States, 90211
    • Florida
      • Brandon, Florida, United States, 33511
      • Jacksonville, Florida, United States, 32204
    • Georgia
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Maryland
      • Annapolis, Maryland, United States, 21401
    • Montana
      • Billings, Montana, United States, 59101
    • New York
      • Williamsville, New York, United States, 14221
    • Ohio
      • Norwood, Ohio, United States, 45212
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Texas
      • Temple, Texas, United States, 76508
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Washington
      • Spokane, Washington, United States, 99218
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: HEALOS and Leopard Cage
Placement in interbody space
Active Comparator: 2
Device: Leopard Cage and Autograft
Placement in the interbody space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

Collaborators

DePuy Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

February 8, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-HEALOS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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