A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

NACompletedINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

August 31, 2017

Study Completion Date

October 31, 2017

Conditions
Lumbar Spinal Stenosis
Interventions
DEVICE

Non-randomized ACADIA® Facet Replacement System

Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

DEVICE

Randomized ACADIA® Facet Replacement System

Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

DEVICE

Randomized Instrumented posterolateral fusion (PLF)

Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Trial Locations (29)

12208

Albany Medical Center, Albany

15212

Allegheny General Hospital, Pittsburgh

19001

Abington Memorial Hospital, Abington

21117

Rubin Institute for Advanced Orthopaedics, Owings Mills

28204

Carolina Neurosurgery and Spine Associates, P.C., Charlotte

28207

OrthoCarolina Spine Center, Charlotte

29406

Charleston Brain & Spine, Charleston

29425

Medical University of South Carolina, Charleston

31405

Neurological Institute of Savannah and Center for Spine, Savannah

33637

Foundation for Orthopaedic Research and Education, Tampa

33765

Florida Spine Institute, Clearwater

37404

The Center for Sports Medicine & Orthopedics, Chattanooga

37620

Neuro-Spine Solutions, Bristol

45242

Riverhills Healthcare, Cincinnati

46032

Indiana Spine Group, Carmel

46804

Fort Wayne Orthopaedics, Fort Wayne

65101

Spine Midwest, Inc., Jefferson City

65804

Springfield Neurological & Spine Institute, Springfield

71101

Spine Institute of Louisiana, Shreveport

78731

Central Texas Spine Institute, Austin

80303

Boulder Neurosurgical & Spine Associates, Boulder

80538

Rocky Mountain Associates (RMA) in Orthopedic Medicine, Loveland

81301

Spine Colorado, Durango

84108

University of Utah, Salt Lake City

90048

Cedars-Sinai Spine Center, Los Angeles

90211

Spine Group Beverly Hills, Beverly Hills

92270

Desert Orthopaedic Center, Rancho Mirage

01605

UMASS Memorial Medical Center, Worcester

00921

University of Puerto Rico, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Globus Medical Inc

INDUSTRY

NCT00401518 - A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis | Biotech Hunter | Biotech Hunter