2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

NAActive, not recruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

August 31, 2025

Study Completion Date

May 13, 2028

Conditions
Symptomatic Cervical Disc Disease
Interventions
DEVICE

prodisc C SK and/or Vivo

Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

DEVICE

Mobi-C Cervical Disc

Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

Trial Locations (30)

10003

NYU Langone Orthopedic Hospital, New York

10021

Hospital for Special Surgery, New York

10075

Northwell Health, Lenox Hill Hospital, New York

14221

Axis Neurosurgery and Spine, Williamsville

17033

Penn State Milton S. Hershey Medical Center, Hershey

20007

Georgetown University Hospital, Washington D.C.

21201

University of Maryland Medical Center, Baltimore

27704

M3-Emerging Medical Resarch, Durham

32204

St. Vincent's Neurosurgery, Jacksonville

33606

University of South Florida, Tampa

33637

Florida Orthopaedic Institute, Temple Terrace

34232

Kennedy-White Orthopaedic Center, Sarasota

42003

Orthopaedic Institute of Western Kentucky, Paducah

44122

SVCMC Solon Medical - Northern Ohio Surgery Center, Beachwood

46032

Indiana Spine Group, Carmel

48073

William Beaumont Hospital, Royal Oak

71101

Spine Institute of Louisiana, Shreveport

75093

Texas Back Institute, Plano

76132

DFW Center for Spinal Disorders, Fort Worth

78231

Texas Spine Care Center, San Antonio

80124

HCA Healthcare, Lone Tree

Sky Ridge Medical Center Campus, Lone Tree

80229

Center for Spine and Orthopedics, Scientific Education and Research Foundation, Thornton

84088

The Disc Replacement Center, Salt Lake City

86001

Flagstaff Bone and Joint, Flagstaff

90048

Doctors Outpatient Center for Surgery, Los Angeles

90210

Todd Lanman, MD, Inc., Beverly Hills

94301

Sutter Health - Palo Alto Medical Foundation, Palo Alto

95816

Sutter Health, Sacramento

07470

University Spine Center, Wayne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centinel Spine

INDUSTRY