RecruitingNot ApplicableNCT04623593

Cervical Arthroplasty Cost Effectiveness Study (CACES)

Economic Evaluation of Anterior Cervical Discectomy With Arthroplasty Versus Anterior Cervical Discectomy With Fusion in the Surgical Treatment of Cervical Degenerative Disc Disease, a Randomized Controlled Trial

Sponsor

Valérie Schuermans

Enrollment

198 participants

Start Date

Jan 17, 2022

Study Type

INTERVENTIONAL

Conditions

Cervical disc degeneration Cervical Spondylosis Cervical Disc Herniation Fusion of Spine Radiculopathy, Cervical Myelopathy Cervical Cervical Fusion Myelopathy, Compressive Radiculopathy, Cervical Region Radiculopathy; in Spondylosis Radiculopathy; in Intervertebral Disc Disorder Myelopathy Neurological Myelopathy Due to Spondylosis Cervical Disc Disease Cervical Disc Disorder With Myelopathy Cervical Disc Prolapse With Myelopathy Cervical Disc Disorder With Radiculopathy Cervical Disc Prolapse With Radiculopathy Disc Prolapse Cervical

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

When the discs and joints in the cervical spine (neck) wear down over time, they can press on nerves or the spinal cord — a condition called cervical degenerative disc disease (CDDD). Surgery is sometimes needed when symptoms like arm pain, numbness, or weakness don't improve with physical therapy. There are two main surgical options: disc replacement (arthroplasty), which preserves neck movement, or spinal fusion, which locks two vertebrae together. This study compares the cost-effectiveness of these two approaches. This is a multi-center randomized trial that will follow patients for several years to track outcomes, costs, and quality of life. Participants must need surgery at one or more cervical levels between C3 and C7. You may be eligible if... - You are 18 years or older - You need anterior cervical decompression surgery - You have symptomatic myelopathy, radiculopathy, or both at C3–C7 - For pure radiculopathy: your symptoms have not improved after at least 6 weeks of conservative therapy You may NOT be eligible if... - You also need a posterior (back-of-neck) surgical approach - You had previous front-of-neck (ventral) cervical surgery - Your compression is from a trauma (injury) - You have metabolic bone disease, Bechterew's disease, or spinal infection - You received prior radiation to the cervical spine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREACDF

Standard operative treatment for anterior cervical discectomy. Through a right or left-sided approach the disc space contents are resected. The endplates are prepared with curettes and the disc space contents are removed. The posterior longitudinal ligament is opened. The dura is visualized to ensure adequate decompression. A cage is implanted in the disc space. The disc removal and cage implantation can be performed at a single level or at multiple levels. The wound is closed in layers, after a prevertebral wound drain is placed.

PROCEDUREACDA

The start of the procedure is the same as in the ACDF group. After the discectomy, a cervical disc prosthesis is placed in the disc space instead of a cage, in accordance with the manufacturer's protocol for implantation and endplate preparation. The disc removal and arthrodesis implantation can be performed at a single level or at multiple levels. Wound closure is similar to the ACDF procedure.