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ACTIVE NOT RECRUITING NA

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

NCT03438747 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 290 participants
Start Date 2018-04-24
Est. Completion 2028-02-28
Phase NA

Sponsor

CeraPedics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03438747

The ClinicalTrials.gov registry entry for NCT03438747 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CeraPedics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03438747 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03438747?

This trial is sponsored by CeraPedics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial