P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
NCT ID: NCT03438747
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
290 participants
INTERVENTIONAL
2018-04-24
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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P-15L Bone Graft
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
P-15L Bone Graft
The investigational group will be treated with P-15L in an instrumented TLIF
Local autologous bone
The active control group will be treated with local autologous bone 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;
Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;
Involved disc(s) between L2 and S1;
Exclusion Criteria
Active malignancy;
Nondiscogenic source of symptoms (e.g. tumor, etc.);
Multiple level symptomatic degenerative disc disease where more than one level requires fusion;
Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;
More than one level to be fused
22 Years
80 Years
ALL
No
Sponsors
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CeraPedics, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CP-1006
Identifier Type: -
Identifier Source: org_study_id
NCT03502057
Identifier Type: -
Identifier Source: nct_alias
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