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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2006
Last Updated Date	February 8, 2011
Start Date ^ICMJE	April 2006
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2011)	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).
Original Primary Outcome Measures ^ICMJE (submitted: April 18, 2006)	Radiographic and clinical
Change History	Complete list of historical versions of study NCT00316121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Official Title ^ICMJE	A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Degenerative Disc Disease
Intervention ^ICMJE	Device: HEALOS and Leopard Cage Placement in interbody space Device: Leopard Cage and Autograft Placement in the interbody space
Study Arm (s)	Experimental: 1 Intervention: Device: HEALOS and Leopard Cage Active Comparator: 2 Intervention: Device: Leopard Cage and Autograft
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	138
Completion Date	Not Provided
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00316121
Other Study ID Numbers ^ICMJE	05-HEALOS-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Manny Lazaro, MS, Advanced Technologies and Regenerative Medicine, LLC
Study Sponsor ^ICMJE	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Collaborators ^ICMJE	DePuy Spine
Investigators ^ICMJE	Not Provided
Information Provided By	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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