P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Degenerative Disc Disease
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria (abbreviated):
Skeletally mature adults between 22 and 80 years old (inclusive);
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 (abbreviated):
Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;
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
Sites / Locations
- The University of Alabama at Birmingham
- Glendale Adventist Medical Center
- Keck School of Medicine USC
- UC Irvine Medical Center
- UC Davis Spine Center
- Cedars-Sinai
- Center for Spine and Orthopedics
- UConn Health
- St. Francis Hospital and Medical Center
- University of South Florida
- Florida Orthopaedic Institute
- Northwestern University
- Rush University Medical Center
- Carle Foundation Hospital
- Indiana Spine Group
- OrthoIndy
- Norton Leatherman Spine Center
- Orthopaedic Institute of Western Kentucky
- University of Michigan
- University Of Buffalo
- The Orthopedic Center at Mount Sinai West
- SUNY Upstate Medical Center
- Duke University Medical Center
- University of Cincinnati
- Cleveland Clinic
- Rothman Institute
- Thomas Jefferson University
- Allegheny Health Network
- University of Pittsburgh Medical Canter
- Austin Neurosurgeons
- Texas Back Institute
- University of Texas Health Science Center at San Antonio
- University of Virginia
- Swedish Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
P-15L Bone Graft
Local autologous bone
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
The active control group will be treated with local autologous bone in an instrumented TLIF