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

April 18, 2006
February 8, 2011
April 2006
January 2010   (final data collection date for primary outcome measure)
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).
Radiographic and clinical
Complete list of historical versions of study NCT00316121 on ClinicalTrials.gov Archive Site
Not Provided
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Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Degenerative Disc Disease
  • Device: HEALOS and Leopard Cage
    Placement in interbody space
  • Device: Leopard Cage and Autograft
    Placement in the interbody space
  • Experimental: 1
    Intervention: Device: HEALOS and Leopard Cage
  • Active Comparator: 2
    Intervention: Device: Leopard Cage and Autograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316121
05-HEALOS-01
Not Provided
Manny Lazaro, MS, Advanced Technologies and Regenerative Medicine, LLC
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
DePuy Spine
Not Provided
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP