Performance of the Hedrocel(R) Cervical Fusion Device - Full Text View

Sponsored by:	Zimmer, Inc.
Information provided by:	Zimmer, Inc.
ClinicalTrials.gov Identifier:	NCT00758758

Purpose

The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft or allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with allograft or autologous bone graft.

Condition	Intervention	Phase
Symptomatic Cervical Disc Disease	Device: Anterior Cervical Discectomy and Fusion	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Performance of the Hedrocel(R) Cervical Fusion Device

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:

Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures) [ Time Frame: 12 and 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

SF-36 [ Time Frame: 12 and 24 Months ] [ Designated as safety issue: No ]

Enrollment:	231
Study Start Date:	December 2001
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental Arm 1: Experimental Hedrocel	Device: Anterior Cervical Discectomy and Fusion Implantation of Hedrocel
Experimental Arm 2: Experimental Hedrocel with a plate	Device: Anterior Cervical Discectomy and Fusion Implantation of Hedrocel
Experimental Arm 3: Experimental 2 Levels Plated Hedrocel	Device: Anterior Cervical Discectomy and Fusion Implantation of Hedrocel
Control Arm 1: Active Comparator Iliac Crest Autograft	Device: Anterior Cervical Discectomy and Fusion Implantation of Autograft
Control Arm 2: Active Comparator Plated Autograft	Device: Anterior Cervical Discectomy and Fusion Implantation of Autograft
Control Arm 3: Active Comparator Plated Allograft	Device: Anterior Cervical Discectomy and Fusion Implantation of Allograft
Control Arm 4: Active Comparator 2 Levels with plated Autograft	Device: Anterior Cervical Discectomy and Fusion Implantation of Autograft
Control Arm 5: Active Comparator 2 Levels with plated Allograft	Device: Anterior Cervical Discectomy and Fusion Implantation of Allograft

Detailed Description:

The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft. Success criteria include radiographic evidence of fusion, and improvement in pain, function and overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion Device would eliminate complications associated with harvesting autologous bone graft and provide an alternative for those who are unable to provide autologous bone graft from the iliac crest.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study.
The patient has no history of previous anterior cervical fusion surgery at the involved levels.
The patient has no history of previous cervical fusion surgery at the adjacent levels.
The patient is willing and able to provide written informed consent.
The patient is likely to complete the required follow-up.

Exclusion Criteria:

The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.
The patient is unable or unwilling to attend postoperative follow-up visits.
The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months.
The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history.
The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously.
The patient has insufficient bone stock to fix the component.
The patient has a known sensitivity to metallic implants.
The patient is a prisoner.
The patient has a Body Mass Index (BMI) greater than or equal to 40.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758758

Locations

United States, California
Cedars-Sinai Medical Center Institute for Spinal Disorders
Los Angeles, California, United States, 90048
United States, Florida
Southeastern Clinic Research
Orlando, Florida, United States, 32804
Orthopaedic Specialties
Clearwater, Florida, United States, 33756
United States, Indiana
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Spine Surgery PSC
Louisville, Kentucky, United States, 40202
United States, Maryland
Four East Madison Orthopaedic Associates, PA
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Boston Spine Group, LLC
Boston, Massachusetts, United States, 02120
United States, Minnesota
Twin Cities Spine Center
Minneapolis, Minnesota, United States, 55404
United States, North Carolina
Orthocarolina
Charlotte, North Carolina, United States, 28207
United States, Tennessee
Vanderbilt Orthopedic Institute
Nashville, Tennessee, United States, 37232-8774
Howell Allen Clinic
Nashville, Tennessee, United States, 37203
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
University of Virginia Health System - Department of Neurosurgery
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Zimmer, Inc.

More Information

Responsible Party:	Zimmer, Inc ( Kristin Jans, Associate Director, Regulatory Affairs )
Study ID Numbers:	IC 003-99
Study First Received:	September 23, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00758758
Health Authority:	United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:

Anterior Cervical Discectomy and Fusion,
Degenerative Disc Disease,
Cervical Spine,
Herniated Disc

ClinicalTrials.gov processed this record on January 16, 2009