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

Conditions

• Degenerative Disc Disease(DDD)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Circumferential Cervical Fusion (CCF) — DEVICE
  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).
• Anterior Cervical Discectomy and Fusion — PROCEDURE
  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.

Study Details

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.

Key Dates

First listed

Jul 23, 2026

Start date

Jun 30, 2026

Status verified

Jul 2026

Primary completion

Dec 1, 2029

Completion

Dec 1, 2029

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Anterior Cervical Discectomy and Fusion (ACDF)
  Anterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure
• Experimental: Circumferential Cervical Fusion (CCF)
  Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF)

Primary Outcome Measure

Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF) [ Time Frame: 12 months ]

Central Contacts

• Matt Jenkins
  805-450-4965
  [email protected]
• Stacey Underwood
  520-262-3704
  [email protected]

Locations (1)

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