A Pivotal Study of the Premia Spine TOPS™ System

NACompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

July 17, 2017

Primary Completion Date

June 27, 2022

Study Completion Date

June 14, 2023

Conditions
Lumbar Spinal StenosisDegenerative Spondylolisthesis
Interventions
DEVICE

Total Posterior Spine System (TOPS)

Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

PROCEDURE

Transforaminal Lumbar Interbody Fusion (TLIF)

Fusion with placement of interbody cage and posterolateral instrumentation

Trial Locations (36)

10075

Lenox Hill Hospital, New York

15212

Allegheny Health Network, Pittsburgh

17011

Orthopedic Institute of Pennsylvania, Harrisburg

19106

UPENN Health Systems Department of Neurosurgery, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

20016

Sibley Hospital/Johns Hopkins, Washington D.C.

23229

Neurosurgical Associates, P.C., Richmond

25755

Marshall University, Huntington

28204

Carolina Neurosurgery & Spine Associates, P.A., Charlotte

31405

Memorial Health University Medical Center, Savannah

32216

St. Vincent's Spine & Brain Institute, Jacksonville

33765

Florida Spine Institute, Clearwater

34119

Physicians Regional Medical Center, Naples

34232

Kennedy White Orthopedic Center, Sarasota

44195

Cleveland Clinic Foundation, Cleveland

45267

Univ. of Cincinnati Medical Center, Cincinnati

46032

Goodman Campbell Brain & Spine, Carmel

48109

University of Michigan Medical Center, Ann Arbor

49007

Bronson Neuroscience Center, Kalamazoo

53212

Wisconsin Bone and Joint S.C., Milwaukee

55905

Mayo Clinic, Rochester

60612

Rush University Medical Center, Chicago

61801

Carle Foundation Hospital, Urbana

75093

Texas Back Institute, Plano

76508

Baylor Scott & White, Temple

77401

Orthopaedic Associates, Bellaire

80045

University of Colorado, Aurora

80303

Boulder Neurosurgical & Spine Associates, Boulder

90048

Cedars Sinai, Los Angeles

91206

Adventist Health Glendale, Glendale

92270

Eisenhower Desert Orthopedic Center, Palm Desert

92868

University of California - Irvine Medical Center, Orange

94117

St. Mary's Medical Center, Spine Center, San Francisco

97504

Southern Oregon Orthopedics, Medford

02115

Brigham and Women's Hospital, Boston

01805

Lahey Clinic, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Premia Spine

INDUSTRY