P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Running, not enrolling · Not applicable
Conditions studied: Degenerative Disc Disease
In brief
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.
Key facts
- Study ID
- NCT03438747
- Run by
- CeraPedics, Inc
- People needed
- 290
- Starts
- 2018-04-24
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2025-10-06
Who can join
Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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