Post-Approval Clinical Trial of the PCM® Cervical Disc

PHASE3CompletedINTERVENTIONAL
Enrollment

494

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
RadiculopathyMyelopathy
Interventions
DEVICE

PCM Cervical Disc

Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1

DEVICE

Anterior Cervical Discectomy and Fusion (ACDF)

Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

Trial Locations (18)

13202

Institute for Spine Care, Syracuse

14094

Buffalo Spine Surgery, Lockport

19107

The Rothman Institute, Philadelphia

21204

Towson Orthopedic Associates, Towson

22601

Virginia Brain and Spine, Winchester

44195

The Cleveland Clinic, Cleveland

46260

Goodman Campbell Brain and Spine, Indianapolis

48034

Wm. Beaumont Hospital, Southfield

54913

NeuroSpine Center of Wisconsin, Appleton

60612

Midwest Orthopedic Associates at Rush, Chicago

60625

Chicago Back Institute, Chicago

65201

Columbia Orthopedic Research, Columbia

73120

Neuroscience Specialists, Oklahoma City

76508

Scott and White Memorial Hospital, Temple

80111

Denver Spine, Greenwood Village

90212

Spine Group Beverly Hills, Beverly Hills

98502

Olympia Othopaedic Associates, Olympia

98431-1100

Madigan Army Medical Center, Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NuVasive

INDUSTRY

NCT01905930 - Post-Approval Clinical Trial of the PCM® Cervical Disc | Biotech Hunter | Biotech Hunter