P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
- Conditions
- Degenerative Disc Disease
- Interventions
- Device: P-15L Bone GraftOther: Local autologous bone in a TLIF with Instrumentation
- Registration Number
- NCT03438747
- Lead Sponsor
- CeraPedics, Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P-15L Bone Graft P-15L Bone Graft The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF Local autologous bone Local autologous bone in a TLIF with Instrumentation The active control group will be treated with local autologous bone in an instrumented TLIF
- Primary Outcome Measures
Name Time Method Neurological deficit 24 Months No new or worsening, persistent neurological deficit
Oswestry Disability Index (ODI) 24 Months At least 15-point improvement in Oswestry Disability Index (ODI)
Fusion 24 Months Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Secondary surgical intervention 24 Months No index level secondary surgical intervention
No serious device-related adverse event 24 Months No serious device-related adverse event
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (34)
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
Norton Leatherman Spine Center
🇺🇸Louisville, Kentucky, United States
Orthopaedic Institute of Western Kentucky
🇺🇸Paducah, Kentucky, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Canter
🇺🇸Pittsburgh, Pennsylvania, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Florida Orthopaedic Institute
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, 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
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
OrthoIndy
🇺🇸Indianapolis, Indiana, United States
University Of Buffalo
🇺🇸Buffalo, New York, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
The Orthopedic Center at Mount Sinai West
🇺🇸New York, New York, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Austin Neurosurgeons
🇺🇸Austin, Texas, United States
Texas Back Institute
🇺🇸Plano, Texas, 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
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States