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Performance of the Hedrocel(R) Cervical Fusion Device

NCT ID: NCT00758758

Last Updated: 2013-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Symptomatic Cervical Disc Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Arm 1

Hedrocel 1 level - No plate

Group Type EXPERIMENTAL

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Hedrocel

Experimental Arm 2

Hedrocel 1 level with plate

Group Type EXPERIMENTAL

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Hedrocel

Experimental Arm 3

Hedrocel 2 levels with plate

Group Type EXPERIMENTAL

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Hedrocel

Control Arm 1

Autograft alone - Illiac crest

Group Type ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Autograft

Control Arm 2

Autograft 1 level with plate

Group Type ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Autograft

Control Arm 3

Allograft 1 level with plate

Group Type ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Allograft

Control Arm 4

Autograft 2 levels with plate

Group Type ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Autograft

Control Arm 5

Allograft 2 levels with plate

Group Type ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type DEVICE

Implantation of Allograft

Interventions

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Anterior Cervical Discectomy and Fusion

Implantation of Hedrocel

Intervention Type DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Allograft

Intervention Type DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Autograft

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cedars-Sinai Medical Center Institute for Spinal Disorders

Los Angeles, California, United States

Site Status

Orthopaedic Specialties

Clearwater, Florida, United States

Site Status

Southeastern Clinic Research

Orlando, Florida, United States

Site Status

Fort Wayne Orthopedics

Fort Wayne, Indiana, United States

Site Status

Spine Surgery PSC

Louisville, Kentucky, United States

Site Status

Four East Madison Orthopaedic Associates, PA

Baltimore, Maryland, United States

Site Status

Boston Spine Group, LLC

Boston, Massachusetts, United States

Site Status

Twin Cities Spine Center

Minneapolis, Minnesota, United States

Site Status

Orthocarolina

Charlotte, North Carolina, United States

Site Status

Howell Allen Clinic

Nashville, Tennessee, United States

Site Status

Vanderbilt Orthopedic Institute

Nashville, Tennessee, United States

Site Status

University of Virginia Health System - Department of Neurosurgery

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Hospital

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IC 003-99

Identifier Type: -

Identifier Source: org_study_id