Cervical Disc Disease

A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management.

Neck pain is a common, multifactorial condition. In the case of degenerative cervical spinal disease, it can result from changes in the intervertebral discs, muscles, intervertebral joints, or sagittal imbalance. Anterior cervical discectomy and fusion (ACDF) is a currently widely accepted procedure for treating cervical degenerative spine disease, with a high patient satisfaction rate. In the current state of knowledge, it is not used for treating axial neck pain, but rather in cases of discopathy causing spinal myelopathy or cervical radiculopathy, in which neck pain often coexists or predominates. The current literature provides ample evidence of the significant effect of ACDF in improving axial neck pain in the conditions mentioned previously. However, little information exists on which patients achieve improvement. The aim of this prospective study is to analyze the outcomes of ACDF in patients with neck pain and to identify predictors of reduction in axial neck pain after ACDF.

To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term. In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months till 4 years postoperatively. High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, to date no prospective trials from a societal perspective exist. Considering the ageing of the population and the rising healthcare costs, the need for a solid clinical cost-effectiveness trial addressing this question is high.