NCT00316121

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 3, 2011

Completed
Last Updated

March 3, 2011

Status Verified

February 1, 2011

Enrollment Period

3.8 years

First QC Date

April 18, 2006

Results QC Date

January 19, 2011

Last Update Submit

February 8, 2011

Conditions

Degenerative Disc Disease

Keywords

One or Two Level Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Device: HEALOS and Leopard Cage

2

ACTIVE COMPARATOR
Device: Leopard Cage and Autograft

Interventions

HEALOS and Leopard CageDEVICE

Placement in interbody space

1
Leopard Cage and AutograftDEVICE

Placement in the interbody space

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Brandon, Florida, 33511, United States

Location

Unknown Facility

Jacksonville, Florida, 32204, United States

Location

Unknown Facility

Savannah, Georgia, 31405, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Annapolis, Maryland, 21401, United States

Location

Unknown Facility

Billings, Montana, 59101, United States

Location

Unknown Facility

Williamsville, New York, 14221, United States

Location

Unknown Facility

Norwood, Ohio, 45212, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73104, United States

Location

Unknown Facility

Eugene, Oregon, 97401, United States

Location

Unknown Facility

Temple, Texas, 76508, United States

Location

Unknown Facility

Salt Lake City, Utah, 84108, United States

Location

Unknown Facility

Spokane, Washington, 99218, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Limitations and Caveats

Stringent criteria for endpoint.Minimum sample size not reached; no hypothesis testing.High portion of current/prior smokers in both groups may impact fusion success.Product usage was appropriate and not low.This study is not on label for HEALOS.

Results Point of Contact

Title
Manny Lazaro, Director, Clinical Affairs
Organization
Advanced Technologies and Regenerative Medicine, LLC
mlazaro@its.jnj.com
508-828-2741

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

April 1, 2006

Primary Completion

January 1, 2010

Last Updated

March 3, 2011

Results First Posted

March 3, 2011

Record last verified: 2011-02

Locations

US(17)