176
Participants
Start Date
May 25, 2021
Primary Completion Date
November 15, 2026
Study Completion Date
November 15, 2029
Lumbar Interbody Fusion
The TLIF/PLIF system includes a TLIF/PLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF/PLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study.
NYU Langone, Spine Research Center, New York
Upstate Orthopedics, East Syracuse
Thomas Jefferson University, Philadelphia
Carolina Neurosurgery and Spine Associates, Charlotte
Pinehurst Surgical Clinic, Pinehurst
Spine & Orthopedic Center, Deerfield Beach
Florida Orthopaedic Institute, Temple Terrace
Center for Sports Medicine and Orthopaedics, Chattanooga
Strenge Spine Institute, Paducah
OrthoNeuro, New Albany
Vertrae, Miamisburg
Mayo Clinic, Rochester
The Spine Center of Louisiana, Baton Rouge
Spine Institute of Louisiana, Shreveport
Oklahoma City Clinical Research Center, Oklahoma City
Ortho San Antonio, San Antonio
Steamboat Orthopedics and Spine Institute (SOSI), Steamboat Springs
The Disc Replacement Center, South Jordan
Todd Lanman MD, Inc., Beverly Hills
University of Colorado, Aurora
Lead Sponsor
MCRA
INDUSTRY
3Spine
INDUSTRY