Performance of the Hedrocel(R) Cervical Fusion Device

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Cervical Disc Disease
• Intervention / Treatment: Device: Anterior Cervical Discectomy and Fusion; Device: Anterior Cervical Discectomy and Fusion; Device: Anterior Cervical Discectomy and Fusion

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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm 1; Hedrocel 1 level - No plate	Device: Anterior Cervical Discectomy and Fusion; Implantation of Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; Device: Anterior Cervical Discectomy and Fusion; Implantation of Autograft
Experimental: Experimental Arm 2; Hedrocel 1 level with plate	Device: Anterior Cervical Discectomy and Fusion; Implantation of Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; Device: Anterior Cervical Discectomy and Fusion; Implantation of Autograft
Experimental: Experimental Arm 3; Hedrocel 2 levels with plate	Device: Anterior Cervical Discectomy and Fusion; Implantation of Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; Device: Anterior Cervical Discectomy and Fusion; Implantation of Autograft
Active Comparator: Control Arm 1; Autograft alone - Illiac crest	Device: Anterior Cervical Discectomy and Fusion; Implantation of Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; 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 Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; 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 Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; Device: Anterior Cervical Discectomy and Fusion; Implantation of Autograft
Active Comparator: Control Arm 4; Autograft 2 levels with plate	Device: Anterior Cervical Discectomy and Fusion; Implantation of Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; 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 Hedrocel; Device: Anterior Cervical Discectomy and Fusion; Implantation of Allograft; Device: Anterior Cervical Discectomy and Fusion; Implantation of Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)	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	12 Months
Neck Disability Index (NDI)	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	12 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Herniated Disc; Degenerative Disc Disease,; Anterior Cervical Discectomy and Fusion,; Cervical Spine,
• Other Study ID Numbers: IC 003-99