Clinical trial NCT00758758: Performance of the Hedrocel(R) Cervical Fusion Device
Official title: Performance of the Hedrocel(R) Cervical Fusion Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Cervical Disc Disease
Keywords: Anterior Cervical Discectomy and Fusion,
Degenerative Disc Disease,
Cervical Spine,
Herniated Disc
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)
timeFrame: 12 Months
measure: Neck Disability Index (NDI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Institute for Spinal Disorders
state: California
city: Clearwater
country: United States
facility: Orthopaedic Specialties
state: Florida
city: Orlando
country: United States
facility: Southeastern Clinic Research
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedics
state: Indiana
city: Louisville
country: United States
facility: Spine Surgery PSC
state: Kentucky
city: Baltimore
country: United States
facility: Four East Madison Orthopaedic Associates, PA
state: Maryland
city: Boston
country: United States
facility: Boston Spine Group, LLC
state: Massachusetts
city: Minneapolis
country: United States
facility: Twin Cities Spine Center
state: Minnesota
city: Charlotte
country: United States
facility: Orthocarolina
state: North Carolina
city: Nashville
country: United States
facility: Howell Allen Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Orthopedic Institute
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Health System - Department of Neurosurgery
state: Virginia
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References: