The CASCADE trial: effectiveness of ceramic versus PEEK cages for anterior cervical discectomy with interbody fusion; protocol of a blinded randomized controlled trial

BMC Musculoskeletal Disorders

Terry P Corbin¹  Jasper FC Wolfs²  Mark P Arts² 

[1] Corbin & Company, Maple Grove, Minnesota, USA;Department of Neurosurgery, Medical Center Haaglanden, PO Box 432, 2501, CK The Hague, The Netherlands

关键词: Herniated disc;    Randomized controlled trial;    Interbody spacers;    PEEK;    Polyetheretherketone;    Silicon nitride;    Anterior cervical discectomy and fusion;   

Others  :  1129961
DOI  :  10.1186/1471-2474-14-244

 received in 2013-03-20, accepted in 2013-08-13,  发布年份 2013

【 摘 要 】

Background

Anterior 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/Design

Patients (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.

Discussion

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. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.

【 授权许可】

   
2013 Arts et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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