Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (CASCADE)

Amedica

Status: Completed

Conditions: Radiating Pain; Cervicobrachial Syndrome; Myelopathy

Treatments: Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage; Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511445

Amedica 2010-1

NL36103.098.11 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

ACDF with PEEK interbody cage

Active Comparator group

Description:

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.

Treatment:

Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

ACDF with Valeo CSC Ceramic Cage

Experimental group

Description:

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.

Treatment:

Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage