P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Public ClinicalTrials.gov record NCT03438747. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03438747
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 290 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- 22 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 24, 2018 (Actual)
- Primary completion
- Feb 28, 2028 (Estimated)
- Completion
- Feb 28, 2028 (Estimated)
- Last update posted
- Oct 6, 2025
2018 – 2028
United States locations
- U.S. sites
- 34
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Glendale Adventist Medical Center | Glendale | California | 91206 | — |
| Keck School of Medicine USC | Los Angeles | California | 90033 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| UC Davis Spine Center | Sacramento | California | 95816 | — |
| Cedars-Sinai | West Hollywood | California | 90069 | — |
| Center for Spine and Orthopedics | Thornton | Colorado | 80229 | — |
| UConn Health | Farmington | Connecticut | 06030 | — |
| St. Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Florida Orthopaedic Institute | Tampa | Florida | 33637 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| OrthoIndy | Indianapolis | Indiana | 46278 | — |
| Norton Leatherman Spine Center | Louisville | Kentucky | 40202 | — |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University Of Buffalo | Buffalo | New York | 14203 | — |
| The Orthopedic Center at Mount Sinai West | New York | New York | 10029 | — |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Canter | Pittsburgh | Pennsylvania | 15213 | — |
| Austin Neurosurgeons | Austin | Texas | 78746 | — |
| Texas Back Institute | Plano | Texas | 73509 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03438747, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03438747 live on ClinicalTrials.gov.