Performance of the Hedrocel(R) Cervical Fusion Device

PHASE3CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

December 31, 2001

Primary Completion Date

January 31, 2009

Study Completion Date

June 30, 2009

Conditions
Symptomatic Cervical Disc Disease
Interventions
DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Hedrocel

DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Allograft

DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Autograft

Trial Locations (13)

21204

Four East Madison Orthopaedic Associates, PA, Baltimore

22031

Inova Fairfax Hospital, Fairfax

22908

University of Virginia Health System - Department of Neurosurgery, Charlottesville

28207

Orthocarolina, Charlotte

32804

Southeastern Clinic Research, Orlando

33756

Orthopaedic Specialties, Clearwater

37203

Howell Allen Clinic, Nashville

40202

Spine Surgery PSC, Louisville

46804

Fort Wayne Orthopedics, Fort Wayne

55404

Twin Cities Spine Center, Minneapolis

90048

Cedars-Sinai Medical Center Institute for Spinal Disorders, Los Angeles

02120

Boston Spine Group, LLC, Boston

37232-8774

Vanderbilt Orthopedic Institute, Nashville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Zimmer Biomet

INDUSTRY