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

This study has been completed.
Sponsor:
Collaborator:
DePuy Spine
Information provided by:
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
ClinicalTrials.gov Identifier:
NCT00316121
First received: April 18, 2006
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Degenerative Disc Disease
Device: HEALOS and Leopard Cage
Device: Leopard Cage and Autograft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Advanced Technologies and Regenerative Medicine, LLC (ATRM):

Primary Outcome Measures:
  • Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 138
Study Start Date: April 2006
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: HEALOS and Leopard Cage
Placement in interbody space
Active Comparator: 2 Device: Leopard Cage and Autograft
Placement in the interbody space

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316121

Locations
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
  More Information

No publications provided

Responsible Party: Manny Lazaro, MS, Advanced Technologies and Regenerative Medicine, LLC
ClinicalTrials.gov Identifier: NCT00316121     History of Changes
Other Study ID Numbers: 05-HEALOS-01
Study First Received: April 18, 2006
Results First Received: January 19, 2011
Last Updated: February 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Technologies and Regenerative Medicine, LLC (ATRM):
One or Two Level Degenerative Disc Disease

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014