Performance of the Hedrocel(R) Cervical Fusion Device

Study Overview
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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.

Official Title
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Performance of the Hedrocel(R) Cervical Fusion Device

Conditions
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Symptomatic Cervical Disc Disease

Intervention / Treatment
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* Device: Anterior Cervical Discectomy and Fusion
* Device: Anterior Cervical Discectomy and Fusion
* Device: Anterior Cervical Discectomy and Fusion


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm 1<br>Hedrocel 1 level - No plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Hedrocel<br>|
| Experimental: Experimental Arm 2<br>Hedrocel 1 level with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Hedrocel<br>|
| Experimental: Experimental Arm 3<br>Hedrocel 2 levels with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Hedrocel<br>|
| Active Comparator: Control Arm 1<br>Autograft alone - Illiac crest | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Autograft<br>|
| Active Comparator: Control Arm 2<br>Autograft 1 level with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Autograft<br>|
| Active Comparator: Control Arm 3<br>Allograft 1 level with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Allograft<br>|
| Active Comparator: Control Arm 4<br>Autograft 2 levels with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Autograft<br>|
| Active Comparator: Control Arm 5<br>Allograft 2 levels with plate | Device: Anterior Cervical Discectomy and Fusion<br>* Implantation of Allograft<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cervical Discectomy and Fusion,, Degenerative Disc Disease,, Cervical Spine,, Herniated Disc