Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
This study has been completed.
Sponsor:
Advanced Technologies and Regenerative Medicine, LLC (ATRM)
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
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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
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:
|
Spinal Diseases Intervertebral Disk Degeneration Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013