Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD

NAActive, not recruitingINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

March 18, 2020

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2025

Conditions
Degenerative Disc Disease
Interventions
PROCEDURE

Anterior Cervical Discectomy and Fusion

Anterior Cervical Decompression and Fusion (ACDF) is a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate.

DEVICE

Posterior Cervical Stabilization System (PCSS)

Posterior Cervical Stabilization System (PCSS) is non-segmental instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PCSS achieves bilateral facet fixation by spanning the interspace at each level with points of fixation at each end of the construct.

Trial Locations (17)

19107

Thomas Jefferson University, Philadelphia

21215

LifeBridge Health - Sinai Hospital of Baltimore, Baltimore

27599

The University of North Carolina at Chapel Hill, Chapel Hill

28374

Pinehurst Surgical Clinic, Pinehurst

28401

Atlantic Neurosurgical & Spine Specialists, Wilmington

42001

The Orthopaedic Institute, Paducah

48073

Beaumont Health, Royal Oak

60612

Rush University Medical Center, Chicago

70112

LSU Health, New Orleans

70808

Bone and Joint Clinic of Baton Rouge, Baton Rouge

71101

Spine Institute of Louisiana, Shreveport

77030

Baylor College of Medicine, Houston

81301

Spine Colorado, Durango

85013

Barrow Neurological Institute, Phoenix

92024

Scripps, Encinitas

95032

OrthoNorCal, Los Gatos

08361

Inspira Health Network, Vineland

All Listed Sponsors
lead

Providence Medical Technology, Inc.

INDUSTRY