Performance of the Hedrocel(R) Cervical Fusion Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00758758
First received: September 23, 2008
Last updated: August 9, 2013
Last verified: August 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 Months ] [ Designated as safety issue: Yes ]
    Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months

  • Neck Disability Index (NDI) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.

    NDI scoring:

    • 0 - 4 = No disability
    • 5 - 14 = Mild disability
    • 15 - 24 = Moderate disability
    • 25 - 34 = Severe disability
    • 35 or over = Complete disability


Enrollment: 231
Study Start Date: December 2001
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm 1
Hedrocel 1 level - No plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Hedrocel
Experimental: Experimental Arm 2
Hedrocel 1 level with plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Hedrocel
Experimental: Experimental Arm 3
Hedrocel 2 levels with plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Hedrocel
Active Comparator: Control Arm 1
Autograft alone - Illiac crest
Device: Anterior Cervical Discectomy and Fusion
Implantation of Autograft
Active Comparator: Control Arm 2
Autograft 1 level with plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Autograft
Active Comparator: Control Arm 3
Allograft 1 level with plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Allograft
Active Comparator: Control Arm 4
Autograft 2 levels with plate
Device: Anterior Cervical Discectomy and Fusion
Implantation of Autograft
Active Comparator: Control Arm 5
Allograft 2 levels with plate
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
Orthopaedic Specialties
Clearwater, Florida, United States, 33756
Southeastern Clinic Research
Orlando, Florida, United States, 32804
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
University of Virginia Health System - Department of Neurosurgery
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00758758     History of Changes
Other Study ID Numbers: IC 003-99
Study First Received: September 23, 2008
Results First Received: May 9, 2013
Last Updated: August 9, 2013
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

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014