Cervical Arthroplasty Cost Effectiveness Study (CACES)

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.

Conditions

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

Interventions

PROCEDURE

ACDF

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.

PROCEDURE

ACDA

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.

Sponsors & Collaborators

• Valérie Schuermans

  lead OTHER

Principal Investigators

• Anouk Smeets, MD, PhD, Professor · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-17

Primary Completion

2026-06-01

Completion

2028-06-01

Countries

• Netherlands

Study Locations