Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (CASCADE)
Radiating Pain, Myelopathy, Cervicobrachial Syndrome
About this trial
This is an interventional treatment trial for Radiating Pain focused on measuring Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.
Eligibility Criteria
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
Sites / Locations
- Medical Center Haaglanden
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ACDF with PEEK interbody cage
ACDF with Valeo CSC Ceramic Cage
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.
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.