Abstract
BackgroundAnterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes.Methods/DesignPatients (age 18–75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes.DiscussionWhile the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.
Highlights
Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation
While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians
Anterior discectomy with fusion (ACDF) using bone graft in dowel or block form can have complications associated with graft collapse and can be associated with pain at the donor site if the graft is harvested from the iliac crest [10]
Summary
A cervical radicular syndrome due to disc herniation is a well-known entity with an annual incidence rate of 83 per 100,000. Various prospective randomised trials have been performed comparing anterior discectomy with additional interbody fusion [3,4,5,6,7,8,9]. There is no consensus on which interbody device to use, currently PEEK cages are considered as the golden standard for anterior cervical discectomy with fusion by many surgeons [15,16,17,18,19]. The present protocol of the CASCADE trial is designed to demonstrate the effectiveness and security of cancellous structured ceramic cages compared to the golden standard PEEK cages in patients treated with anterior cervical discectomy and fusion.
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