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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Indication for anterior cervical decompression surgery.

• Single- or multilevel CDDD between C3 and C7.

• Symptoms of myelopathy, radiculopathy, or myeloradiculopathy.

• In case of pure radiculopathy: refractory to at least 6 weeks of conservative therapy.

• In case of myelopathy: symptomatic myelopathy.

• Patients ≥ 18 years of age.

Locations
Other Locations
Netherlands
Zuyderland Medical Center
RECRUITING
Maastricht
Contact Information
Primary
Valérie Schuermans, MD
valerie.schuermans@mumc.nl
0031433875001
Backup
Anouk Smeets, MD, PhD
anouk.smeets@mumc.nl
0031433875001
Time Frame
Start Date: 2022-01-17
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 198
Treatments
Active_comparator: ACDF
Anterior cervical discectomy and fusion.
Experimental: ACDA
Anterior cervical discectomy with arthroplasty.
Sponsors
Leads: Valérie Schuermans

This content was sourced from clinicaltrials.gov