Cervical Arthroplasty Cost Effectiveness Study (CACES)

NARecruitingINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

January 17, 2022

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2028

Conditions
Radiculopathy, CervicalMyelopathy CervicalMyelopathy, CompressiveRadiculopathy, Cervical RegionRadiculopathy; in SpondylosisRadiculopathy; in Intervertebral Disc DisorderMyelopathy NeurologicalMyelopathy Due to SpondylosisCervical Disc DiseaseCervical Disc HerniationCervical Disc DegenerationCervical Disc Disorder With MyelopathyCervical Disc Prolapse With MyelopathyCervical SpondylosisCervical FusionCervical Disc Disorder With RadiculopathyCervical Disc Prolapse With RadiculopathyFusion of SpineDisc 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.

Trial Locations (1)

6419 PC

RECRUITING

Zuyderland Medical Center, Maastricht

All Listed Sponsors
lead

Valérie Schuermans

OTHER