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

Degenerative Disc Disease Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316121
• Other study ID #: 05-HEALOS-01
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2006
• Last updated: February 8, 2011
• Start date: April 2006

Study information

• Verified date: February 2011
• Source: Advanced Technologies and Regenerative Medicine, LLC (ATRM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• HEALOS and Leopard Cage
Placement in interbody space
• Leopard Cage and Autograft
Placement in the interbody space

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Technologies and Regenerative Medicine, LLC (ATRM)	DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 months	No