Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

Study Overview
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Brief Summary
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This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Official Title
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Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.

Conditions
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Radiating Pain, Myelopathy, Cervicobrachial Syndrome

Intervention / Treatment
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* Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
* Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 75 years Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy. At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication) Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms Ability and willingness to comply with project requirements Written informed consent given by the subject or the subject's legally authorised representative Exclusion Criteria: Previous cervical surgery (either anterior or posterior) Increased motion on dynamic studies (> 3 mm) Severe segmental kyphosis of the involved disc level (> 7 degrees) Patient cannot be imaged with MRI Neck pain only (without radicular or medullary symptoms) Infection Metabolic and bone diseases (osteoporosis, severe osteopenia) Neoplasma or trauma of the cervical spine Spinal anomaly (Klippel Feil, Bechterew, OPLL) Severe mental or psychiatric disorder Inadequate Dutch language Planned (e)migration abroad in the year after inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACDF with PEEK interbody cage<br>Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure. | Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage<br>* Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer<br>* Other names: Medicrea Manta or similar PEEK cage;|
| Experimental: ACDF with Valeo CSC Ceramic Cage<br>ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood. | Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage<br>* Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.<br>* Other names: Silicon Nitride ceramic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index | The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months. | 24 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Status | Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available. | 3 mo., 6mo., 12 mo., 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.