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Trial record 1 of 1 for:    NCT00316121
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Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316121
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : March 3, 2011
Last Update Posted : March 3, 2011
DePuy Spine
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: HEALOS and Leopard Cage Device: Leopard Cage and Autograft Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
Study Start Date : April 2006
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316121

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

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Responsible Party: Manny Lazaro, MS, Advanced Technologies and Regenerative Medicine, LLC Identifier: NCT00316121    
Other Study ID Numbers: 05-HEALOS-01
First Posted: April 20, 2006    Key Record Dates
Results First Posted: March 3, 2011
Last Update Posted: March 3, 2011
Last Verified: February 2011
Keywords provided by Advanced Technologies and Regenerative Medicine, LLC (ATRM):
One or Two Level Degenerative Disc Disease
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases