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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HEALOS and Leopard Cage
Leopard Cage and Autograft
Sponsored by
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring One or Two Level Degenerative Disc Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
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).

Secondary Outcome Measures

Full Information

First Posted
April 18, 2006
Last Updated
February 8, 2011
Sponsor
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Collaborators
DePuy Spine
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1. Study Identification

Unique Protocol Identification Number
NCT00316121
Brief Title
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Official Title
A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Collaborators
DePuy Spine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
One or Two Level Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
HEALOS and Leopard Cage
Intervention Description
Placement in interbody space
Intervention Type
Device
Intervention Name(s)
Leopard Cage and Autograft
Intervention Description
Placement in the interbody space
Primary Outcome Measure Information:
Title
Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Description
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).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Norwood
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

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

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