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NCT03438747 · ClinicalTrials.gov registry record · NA
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
A NA study of Degenerative Disc Disease, sponsored by CeraPedics.
- Active
- Registry status
- NA
- Development phase
- 290
- Enrollment target
- 20
- Study locations
NCT03438747: Active NA study of Degenerative Disc Disease, sponsored by CeraPedics.
NCT03438747 is a NA study of Degenerative Disc Disease that is active but no longer recruiting, run by CeraPedics. The registered enrollment target is 290 participants, above the 162-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03438747, a NA study of Degenerative Disc Disease, is active but no longer recruiting, sponsored by CeraPedics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
No index level secondary surgical intervention
Conditions Studied
Interventions
- DEVICE P-15L Bone Graft
- OTHER Local autologous bone in a TLIF with Instrumentation
Study Locations (20)
California
- Glendale Adventist Medical Center - Glendale
- Keck School of Medicine USC - Los Angeles
- UC Irvine Medical Center - Orange
- UC Davis Spine Center - Sacramento
- Cedars-Sinai - West Hollywood
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- Carle Foundation Hospital - Urbana
Connecticut
- UConn Health - Farmington
- St. Francis Hospital and Medical Center - Hartford
Florida
- University of South Florida - Tampa
- Florida Orthopaedic Institute - Tampa
Indiana
- Indiana Spine Group - Carmel
- OrthoIndy - Indianapolis
Kentucky
- Norton Leatherman Spine Center - Louisville
- Orthopaedic Institute of Western Kentucky - Paducah
Alabama
- The University of Alabama at Birmingham - Birmingham
Colorado
- Center for Spine and Orthopedics - Thornton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2028-02-28 |
| Phase | NA |
What the registry record for NCT03438747 still lists
NCT03438747 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which P-15L Bone Graft is the first listed.
NCT03438747 names 20 study sites across 10 states, led by California, Illinois, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03438747 about?
NCT03438747 is a clinical study titled "P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation". 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 subject...
What is the current status of trial NCT03438747?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 290 participants. The study started on 2018-04-24. Estimated completion is 2028-02-28.
What conditions does trial NCT03438747 study?
This clinical trial studies the following conditions: Degenerative Disc Disease.
What interventions are being tested in trial NCT03438747?
The interventions under investigation include: P-15L Bone Graft (DEVICE), Local autologous bone in a TLIF with Instrumentation (OTHER).
Who is sponsoring clinical trial NCT03438747?
This trial is sponsored by CeraPedics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03438747 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03438747's enrollment target sits among peer trials
290 8th of 42 higher than 35 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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