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NOT YET RECRUITING
NCT07721493
NA

Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

Sponsor: Providence Medical Technology, Inc.

View on ClinicalTrials.gov

Summary

The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures. The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit. Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.

Official title: An Assessment of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) to Determine Superiority to ANterior Cervical Discectomy and Fusion (ACDF) in the Treatment of 2-Level Cervical Degenerative Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2026-06-30

Completion Date

2029-12-01

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DEVICE

Circumferential Cervical Fusion (CCF)

Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM).

PROCEDURE

Anterior Cervical Discectomy and Fusion

ACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs.

Locations (1)

The Orthopaedic Institute

Paducah, Kentucky, United States