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P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Sponsor: CeraPedics, Inc
Summary
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.
Official title: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2018-04-24
Completion Date
2028-02-28
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
P-15L Bone Graft
The investigational group will be treated with P-15L in an instrumented TLIF
Local autologous bone in a TLIF with Instrumentation
The active control group will be treated local autologous bone in an instrumented TLIF
Locations (34)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Glendale Adventist Medical Center
Glendale, California, United States
Keck School of Medicine USC
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
UC Davis Spine Center
Sacramento, California, United States
Cedars-Sinai
West Hollywood, California, United States
Center for Spine and Orthopedics
Thornton, Colorado, United States
UConn Health
Farmington, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
OrthoIndy
Indianapolis, Indiana, United States
Norton Leatherman Spine Center
Louisville, Kentucky, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University Of Buffalo
Buffalo, New York, United States
The Orthopedic Center at Mount Sinai West
New York, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Canter
Pittsburgh, Pennsylvania, United States
Austin Neurosurgeons
Austin, Texas, United States
Texas Back Institute
Plano, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States